Northeast Scientific Receives FDA 510K Clearance on Reprocessed RF Stylet

Northeast Scientific Inc. (NES), known for its advanced medical device reprocessing capability, received 510K clearance from the U.S. Food and Drug Administration (FDA) for the RF Stylet manufactured by Covidien, a division of Medtronic plc.
 
This FDA clearance gives NES the green light to reprocess and market the stylet. The device, originally manufactured by VNUS, is used in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins.
 
“The proprietary systems we have built for the ClosureFast RF Ablation Catheter are just a natural fit for the RF Stylet,” said NES CEO Craig Allmendinger.
 
NES has sold over 250,000 ClosureFast RF Ablation devices since 2012 with superior safety results.
 
“The Stylet will get the same rigorous treatment as ClosureFast,” Allmendinger said. “The market has come to love the efficiency of our reprocessing service and they will get the same with this device.”
 
Reprocessing under an FDA 510K allows doctors to use a single-use device several times and reduce their costs. The NES focus on reprocessing more complex and costly devices provides even greater savings for end-users. Some NES customers save over $100,000 annually with just the Reprocessed ClosureFast RF Ablation catheter alone.
 
Reprocessing also prolongs the useful life of millions of devices, reducing the tonnage that finds its way to landfills or to the incinerator each year.
 
Northeast Scientific Inc., based in Waterbury, Conn., is registered with the FDA as both a reprocessor of single-use medical devices and a manufacturer. Founded in 2005, NES received its first 510(k) clearance in 2007, has added new products to its reprocessing suite and is developing multiple 510(k)s in the vascular space. NES is ISO 13485 2016 certified.