KNS · Class II · 21 CFR 876.4300

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 Corp, Boston Scientific Corporation and Aqua Medical, Inc..

188
Total
188
Cleared
106d
Avg days
1976
Since
Growing category - 14 submissions in the last 2 years vs 11 in the prior period
Review times increasing: avg 152d recently vs 103d historically

FDA 510(k) Cleared Unit, Electrosurgical, Endoscopic (with Or Without Accessories) Devices (Product Code KNS)

188 devices
1–24 of 188
Cleared May 21, 2026
Sphincterotome
K260962
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 59d
Cleared Nov 26, 2025
Vanquish Water Vapor Ablation Device
K252388
Francis Medical, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 25, 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889
Olympus Medical Systems Corporation
Gastroenterology & Urology · 76d
Cleared Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945
Olympus Medical Systems Corp.
Gastroenterology & Urology · 203d
Cleared Oct 10, 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351
Olympus Medical Systems Corporation
Gastroenterology & Urology · 245d
Cleared Sep 29, 2025
SureTome™ SW Sphincterotome with DomeTip
K251104
Wilson Cook Medical
Gastroenterology & Urology · 171d
Cleared Aug 08, 2025
Aqua Medical RF Vapor Ablation System
K251226
Aqua Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Jun 11, 2025
Rezum System
K250584
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared Jun 06, 2025
SpydrBlade Flex Instrument (PRD-RG1-001)
K242774
Creo Medical, Ltd.
Gastroenterology & Urology · 266d
Cleared Mar 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
K241855
Sb-Kawasumi Laboratories, Inc.
Gastroenterology & Urology · 272d
Cleared Feb 06, 2025
Disposable Sphincterotome
K242192
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Jan 17, 2025
Teslatome Bipolar Sphincterotome
K243568
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Dec 12, 2024
Aqua Medical RF Vapor Ablation System
K241271
Aqua Medical, Inc.
Gastroenterology & Urology · 220d
Cleared Aug 15, 2024
Reusable Interface Cable 1.5 m (PRD-IFC-002)
K242061
Creo Medical, Ltd.
Gastroenterology & Urology · 31d
Cleared Mar 29, 2024
Disposable Sphincterotome
K232825
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Gastroenterology & Urology · 198d
Cleared Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
K232633
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Nov 07, 2023
Disposable Sphincterotome
K232476
Zhejiang Soudon Medical Technology Co., Ltd.
Gastroenterology & Urology · 83d
Cleared Oct 31, 2023
Speedboat Flush SB1 Instrument
K230328
Creo Medical, Ltd.
Gastroenterology & Urology · 267d
Cleared Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
K233318
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Oct 25, 2023
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
K233113
Starmed Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
K232162
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Jun 21, 2023
Habib EndoHPB
K231533
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared May 03, 2023
Sphincterotome
K222421
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Apr 05, 2023
Optimos™ Cystotome
K223256
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 166d

About Product Code KNS - Regulatory Context

510(k) Submission Activity

188 total 510(k) submissions under product code KNS since 1976, with 188 receiving FDA clearance (average review time: 106 days).

Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KNS Product Code

Recent submissions under KNS have taken an average of 152 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 →