Cleared Traditional

AcuSnare Polypectomy Snare (K173673) - FDA 510(k) Clearance

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

K173673 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Aug 2018
Decision
267d
Days
Class 2
Risk

K173673 is an FDA 510(k) clearance for the AcuSnare Polypectomy Snare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on August 24, 2018 after a review of 267 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K173673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2017
Decision Date August 24, 2018
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 K173673.
AcuSnare Polypectomy Snare - Duckbill
K191048 · Wilson-Cook Medical, Inc. · Jul 2019
ClearGrasp Snare
K183289 · Finemedix Co., Ltd. · Mar 2019
Roth Net Retriever Product Line
K182909 · United States Endoscopy Group, Inc. · Nov 2018
Polypectomy Snare
K172729 · Hangzhou AGS MedTech Co., Ltd. · May 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