Cleared Traditional

K210406 - Bipolar Coagulation Foreceps

K210406 is an FDA 510(k) clearance for Bipolar Coagulation Foreceps, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K210406 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
237d
Days
Class 2
Risk

K210406 is an FDA 510(k) clearance for the Bipolar Coagulation Foreceps. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 5, 2021 after a review of 237 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 - K210406

510(k) Number K210406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2021
Decision Date October 05, 2021
Days to Decision 237 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
107d slower than avg
Panel avg: 130d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
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 - KGE Forceps, Biopsy, Electric

All 28
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K210406.
ClearHemograsper
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K202438 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2021
Avulsion Forceps
K183428 · STERIS Corporation · Apr 2019
Disposable Hot Biopsy Forceps
K180018 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2018