Search Results for '510(k)'
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Surgical
HemoSonics Gains Special FDA 510(k) Clearance for Quantra QStat Cartridge
The expanded use of the Quantra Hemostasis Analyzer allows for further standardization and operationalized viscoelastic testing.Rachel Klemovitch, Assistant Editor 04.05.24
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Diagnostics
FDA Grants Endostart’s Endorail with 510(k) Clearance
The next-generation magnetic balloon technology advances the field of gastrointestinal endoscopy.Rachel Klemovitch, Assistant Editor 03.26.24
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Surgical
Pulse Biosciences Gains 510(k) Clearance for Percutaneous Electrode System
The CellFX nsPFA is used in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.Sean Fenske, Editor-in-Chief 03.11.24
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Chronic Disease
Embecta Submits Insulin Patch Pump for FDA 510(k) Review
The discreet pump features a 300U insulin reservoir.Sam Brusco, Associate Editor 01.09.24
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Pulse Biosciences Files 510(k) for CellFX nsPFA Cardiac Clamp
A device designed to produce linear transmural ablations during cardiac surgeries.Rachel Klemovitch, Assistant Editor 01.02.24
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BD Receives FDA 510(k) Clearances for Fingertip Blood Collection System
The BD MiniDraw Capillary Blood Collection System is less invasive than a traditional venous blood draw and more convenient.Charles Sternberg, Associate Editor 12.07.23
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Packaging & Sterilization
Andersen Sterilizers Nabs First 510(k) Master File for EO Sterility Change
Companies can reference the Andersen Sterilizers master file instead of submitting a new 510(k) for the sterilization change.Sam Brusco, Associate Editor 08.14.23
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Diagnostics
BD Receives FDA 510(k) Clearance for BD Kiestra MRSA Imaging Application
Uses artificial intelligence (AI) to interpret bacterial growth and release negative specimens with minimal human interaction.Charles Sternberg, Associate Editor 05.16.23
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Diagnostics
Mawi DNA’s iSWAB-RC-EL for SARS-CoV-2 Granted 510(k) Clearance
Mawi DNA developed the iSWAB-RC-EL bio sampling device for surveillance testing of COVID-19 and its variants in any clinical setting.Charles Sternberg, Associate Editor 04.26.23
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Surgical
Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
Seeking indication for coagulation of subcutaneous soft tissues where needed, following liposuction.Sam Brusco, Associate Editor 02.03.23
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FDA’s Refusal to Accept Policy for 510(k)s—Mike on Medtech
Mike Drues and Sean Fenske review the latest guidance on Refuse to Accept and why the occurrence happens much too often.Sean Fenske, Editor-in-Chief 10.18.22
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Northeast Scientific Wins 510(k) for Laser Atherectomy Catheter Reprocessing
The device is used to treat peripheral arterial disease (PAD) and emits high energy ultraviolet light to vaporize blockages inside the vessels.Michael Barbella, Managing Editor 09.01.22
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Diagnostics
Collaboration Live by Royal Philips Receives Expanded FDA 510(k) Market Clearance
Allows clinicians to collaborate in real-time with colleagues in order to complete image acquisition and diagnosis remotely.Charles Sternberg, Associate Editor 03.14.22
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Chronic Disease
BreatheSuite Receives FDA 510(K) Clearance for Metered-Dose Inhaler V1 Device
The device and mobile app work together to evaluate and “score” a person’s inhaler technique and usage patterns.BreatheSuite 10.04.21
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Surgical
RonovoRx's RenovoCath Earns New FDA 510(k)
Use of RenovoCath may improve targeted delivery of chemotherapy.PR Newswire 09.07.21
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Chronic Disease
Koya Medical Receives FDA 510(k) Clearance for Active Compression Therapy System
Appoints additional executive leaders to support commercialization.Charles Sternberg, Assistant Editor 06.02.21
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Patient Monitoring
FDA Grants 510(k) Clearance to LivaNova’s B-Capta
An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.Charles Sternberg, Assistant Editor 04.20.21
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Chronic Disease
BD Receives 510(k) Clearance for Pristine Catheter
The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.Charles Sternberg, Assistant Editor 04.15.21
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Surgical
Royal Philips’ SmartCT Application Software Receives FDA 510(k) Clearance
Helps enhance clinical confidence, smooths workflows, and increases productivity.Charles Sternberg, Assistant Editor 04.06.21
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Venus Concept Wins FDA 510(k) Clearance for Venus Viva MD
The new skin rejuvenation solution with differentiated features allows clinicians to treat a wider range of conditions.Globe Newswire 09.02.20
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Northeast Scientific Wins 510(k) for IVUS Catheter Reprocessing
The clearance is the second received by the company for IVUS catheter reprocessing.Globe Newswire 08.24.20
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Getinge's Servo-air Mechanical Ventilator Receives 510(k) Clearance
Includes both Invasive and Non-Invasive (NIV) ventilation modes.Getinge 07.07.20
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FDA Continues User-Fee Related Reviews Through COVID-19
FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.U.S. Food and Drug Administration 04.17.20
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Materials | Testing
Particle Particulars: Why this Analysis Is Foundational for Successful Devices
In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.Dawn A. Lissy, President & Founder, Empirical 03.04.20
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FDA 510(k) Clears US Medical Innovations' Canady Plasma Smart XL-1000 Generator
The product is the first SMART electrosurgical generator in the world with its own operating system.Business Wire 01.21.20
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Safety and Performance Based 510(k)—Mike on Medtech
Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.Sean Fenske, Editor-in-Chief 12.05.19
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The Special 510(k) Program—Mike on Medtech
Mike Drues and Sean Fenske discuss a 510(k) option for modifications to a company's legally marketed medical device.Sean Fenske, Editor-in-Chief 11.13.19
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FDA Awards 510(k) Clearance to Laser Associated Sciences' FlowMet-R
The technology includes a small laser diode and a camera the size of a postage stamp to measure blood flow in the digit in real time.PR Newswire 11.13.19
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Cardiovascular | Diagnostics | Software & IT
HeartVista Receives FDA 510(k) Clearance for Cardiac MRI Package
Prescribes the standard cardiac views with just one click.HeartVista 10.29.19
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Beyond 510(k)/PMA: Safer Technologies Program—Mike on Medtech
Sean Fenske and Mike Drues discuss another new program from the FDA—the Safer Technologies Program (STeP)—and the details of it.Sean Fenske, Editor-in-Chief 10.17.19
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MPO Summit 2019 Conference Program Notebook
An ongoing update of MPO Summit 2019 sessions.Online Exclusives Michael Barbella, Managing Editor 10.03.19
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Apyx Medical Adds to its Clinical and Regulatory Affairs Teams
Company appoints senior director of Clinical Studies and global director of Regulatory Affairs.Business Wire 09.25.19
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FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway.U.S. Food and Drug Administration 09.20.19
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Surgical
Apollo Endosurgery Receives 510(k) Clearance for Suture-Anchor Component
Reduces dependency on third party suppliers.Apollo Endosurgery 09.18.19
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Cardiovascular
Netech Obtains FDA 510(k) Clearance for Delta 3300
An instrument for testing defibrillators and pacemakers.PRNewswire 09.09.19
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U.S. May Offer a Safe Harbor from the Impending MDR Storm
U.S. may represent the preferred route to market with regulatory changes elsewhere in the world, like the EU's MDR.Dawn A. Lissy, President & Founder, Empirical 09.06.19
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Diagnostics
FDA OKs Shimadzu's FLUOROspeed X1 RF system
FLUOROspeed X1 is a conventional RF table system offering high image quality and a multitude of features that improve workflow and operator efficiencies.PR Newswire 08.12.19
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PAVmed Subsidiary Lucid Diagnostics Receives FDA 510(k) Clearance for EsoCheck
EsoCheck is a non-invasive cell collection device designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure.Globe Newswire 08.08.19
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Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech
Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.Sean Fenske, Editor-in-Chief 08.06.19
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Beyond 510(k)/PMA: De Novo 101—Mike on Medtech
Sean Fenske and Mike Drues discuss the third most common regulatory pathway—the De Novo—clearing up details about its advantages and when it's used.Sean Fenske, Editor-in-Chief 07.02.19
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Ethicon Receives FDA 510(k) Clearance for VISTASEAL Open and Laparoscopic Dual Applicator Devices
VISTASEAL Dual Applicator is the first product to emerge from recent strategic partnership between Ethicon and Grifols.Johnson & Johnson Medical Devices Companies 06.19.19
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RMS Medical Products Receives FDA 510(k) Clearance for HIgh-Flo Super26 Subcutaneous Needle Sets
The needle sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings.Businesswire 06.04.19
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IRADIMED Receives FDA 510(k) Clearance for Neonatal Pulse Oximetry and Capnography Monitoring
Clearance allows for neonatal use of the SpO2 and CO2 features of the 3880 MRI-compatible patient vital signs monitor.05.15.19
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FDA Provides Further Update on 510(k) Modernization Efforts
The agency believes that additional changes are needed to fully modernize the 510(k) program.Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration 04.30.19
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Axilum Robotics Announces FDA 510(k) Clearance for TMS-Cobot
The TMS-Cobot TS MV aids in the precise implementation of Transcranial Magnetic Stimulation.Business Wire 04.05.19
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Sofregen Medical Receives FDA 510(k) Clearance for Silk Voice
Product is the first and only FDA-cleared product made from solubilized silk protein.Business Wire 03.05.19
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Patient Monitoring
IRADIMED Corporation Announces 510(k) Clearance of Invasive Blood Pressure Module
Product is designed for use with the company's MRI-compatible patient vital signs monitor.Globe Newswire 02.05.19
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Continuing on the 510(k) Pathway or Finding a Different Route?
...Sean Fenske, Editor-in-Chief 01.30.19
