Cleared Traditional

K172729 - Polypectomy Snare

K172729 is an FDA 510(k) clearance for Polypectomy Snare, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K172729 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
252d
Days
Class 2
Risk

K172729 is an FDA 510(k) clearance for the Polypectomy Snare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 21, 2018 after a review of 252 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 - K172729

510(k) Number K172729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2017
Decision Date May 21, 2018
Days to Decision 252 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
122d slower than avg
Panel avg: 130d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDI Device Classification - Class 2, Special Controls

Product Code FDI Snare, Flexible
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 Consultant

Shanghai Thinkwell Consulting Co., Ltd.
Ethan Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FDI Snare, Flexible

All 47
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K172729.
ClearGrasp Snare
K183289 · Finemedix Co., Ltd. · Mar 2019
Roth Net Retriever Product Line
K182909 · United States Endoscopy Group, Inc. · Nov 2018
AcuSnare Polypectomy Snare
K173673 · Wilson-Cook Medical, Inc. · Aug 2018
Rotatable Snares, Non-Rotatable Snares
K172758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2018
Single Use Electrosurgical Snare SD-400
K172734 · Olympus Medical Systems Corp. · Dec 2017
Rotatable Snares
K160637 · Boston Scientific Corporation · Mar 2016