Cleared Traditional

K201121 - Sphincterotome

K201121 is an FDA 510(k) clearance for Sphincterotome, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K201121 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
284d
Days
Class 2
Risk

K201121 is an FDA 510(k) clearance for the Sphincterotome. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 5, 2021 after a review of 284 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou AGS MedTech Co., Ltd. devices

FDA 510(k) Submission Details - K201121

510(k) Number K201121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date February 05, 2021
Days to Decision 284 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 130d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 119
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K201121.
RF Vapor System
K213627 · Aqua Medical, Inc. · Dec 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
K210934 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2021
Aqua Medical RF Vapor System
K211282 · Aqua Medical, Inc. · May 2021
ORISE ProKnife
K200404 · Boston Scientific Corporation · Dec 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
K192342 · Hangzhou AGS MedTech Co., Ltd. · May 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · Creo Medical, Ltd. · Mar 2020