Cleared Traditional

Sphincterotome (K201121) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201121 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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 81
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