Cleared Special

AcuSnare Polypectomy Snare - Duckbill

K191048 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology
Jul 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K191048 is an FDA 510(k) clearance for the AcuSnare Polypectomy Snare - Duckbill, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on July 18, 2019, 90 days after receiving the submission on April 19, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K191048 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2019
Decision Date July 18, 2019
Days to Decision 90 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FDI — Snare, Flexible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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