FDA OKs Karl Storz’s FIVE S 6.5 Single-Use Bronchoscope

Karl Storz has earned U.S. Food and Drug Administration (FDA) clearance for its FIVE S 6.5 sterile, single-use bronchoscope.

The device provides a new option for critical care physicians, intensivists, RTs, and ICU-based proceduralists looking for airway control solutions for high-risk patients. This is especially helpful for those managing heavy secretions in urgent situations needing fast airway clearance.

The FIVE S 6.5 bronchoscope has a large 3 mm working channel to deliver powerful suction. During bench testing, the device cleared 15 mL of simulated mucus (prepared using egg whites) in under five seconds.

The device was designed to perform like a reusable scope, the company said. It features a reinforced shaft and specialized tip engineered to support controlled navigation and scope positioning in challenging airways. Its contoured grip and balanced weight are designed to support maneuverability and operator comfort during long procedures.

The bronchoscope integrates with the company’s C-MAC monitor for consistent illumination and clear image quality. It has support for accessories up to 2.4 mm outer diameter, allowing use with both single-use and reusable instruments.

“The FIVE S 6.5 single-use bronchoscope delivers precise articulation, powerful secretion clearance, and sharp visualization,” said Jennifer Jackson, Executive Director, Sales & Marketing, Airway and Emergency Medicine at KARL STORZ North America. “Whether performing bronchoscopy, lavage, or airway inspection, the FIVE S 6.5 provides the reliability you need when every second counts.”

“At KARL STORZ, we understand that managing costs goes far beyond purchase price and encompasses workflow efficiency, reliability, performance, reprocessing, and infection control,” Jackson went on. “With the FIVE S 6.5—as with the entire FIVE product family—we help our partners address all of these concerns though a single cost-effective, low-maintenance, contamination-reducing solution.”