Karl Storz SE & CO. KG - FDA 510(k) Cleared Devices

Karl Storz SE & CO. KG, is a medical device manufacturer headquartered in Tuttlingen, Germany. The company specializes in endoscopic instruments and visualization systems for surgical and diagnostic procedures.

The company has received 25 FDA 510(k) clearances from 25 total submissions since 2018. Karl Storz devices span multiple surgical specialties, with particular strength in Gastroenterology & Urology applications. The latest FDA 510(k) clearance was granted in 2026, confirming the company's active regulatory engagement.

Recent cleared devices include flexible video endoscopes, telescopes for urological procedures, mediastinoscopes for ENT applications, and advanced imaging systems. The product portfolio reflects core competencies in minimally invasive visualization, airway management, and surgical instrumentation across general surgery, otolaryngology, and urology.

Explore the complete list of device names, product codes, and individual clearance dates in the database.

Regulatory submissions have been managed by Karl Storz Endoscopy America, Inc. and Karl Storz Endoscopy America.