FDA Product Code KNS: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
FDA product code KNS covers endoscopic electrosurgical units used for cutting and coagulation during gastrointestinal endoscopy.
These systems deliver high-frequency electrical current through endoscopic accessories — including snares, forceps, and knives — to resect polyps, cut tissue, and control bleeding during procedures such as polypectomy, endoscopic mucosal resection, and sphincterotomy.
KNS devices are Class II medical devices, regulated under 21 CFR 876.4300 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Boston Scientific Corporation, Aqua Medical, Inc. and Creo Medical, Ltd..
FDA 510(k) Cleared Unit, Electrosurgical, Endoscopic (with Or Without Accessories) Devices (Product Code KNS)
About Product Code KNS - Regulatory Context
510(k) Submission Activity
187 total 510(k) submissions under product code KNS since 1976, with 187 receiving FDA clearance (average review time: 107 days).
Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.
FDA Review Time
Recent submissions under KNS have taken an average of 159 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
KNS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →