Cleared Traditional

Rotatable Snares, Non-Rotatable Snares (K172758) - FDA 510(k) Clearance

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

K172758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
175d
Days
Class 2
Risk

K172758 is an FDA 510(k) clearance for the Rotatable Snares, Non-Rotatable Snares. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hanzhou, CN). The FDA issued a Cleared decision on March 7, 2018 after a review of 175 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K172758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2017
Decision Date March 07, 2018
Days to Decision 175 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
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - FDI Snare, Flexible

All 35
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K172758.
Roth Net Retriever Product Line
K182909 · United States Endoscopy Group, Inc. · Nov 2018
AcuSnare Polypectomy Snare
K173673 · Wilson-Cook Medical, Inc. · Aug 2018
Polypectomy Snare
K172729 · Hangzhou AGS MedTech Co., Ltd. · May 2018
Single Use Electrosurgical Snare SD-400
K172734 · Olympus Medical Systems Corp. · Dec 2017
Rotatable Snares
K160637 · Boston Scientific Corporation · Mar 2016
Lariat snare
K151197 · United States Endoscopy Group, Inc. · Jul 2015