Cleared Traditional

K172758 - Rotatable Snares

K172758 is an FDA 510(k) clearance for Rotatable Snares, manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K172758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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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

FDA 510(k) Submission Details - K172758

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.

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 Peers - FDI Snare, Flexible

All 47
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K172758.
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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
rescuenet
K152580 · Endochoice, Inc. · Nov 2015