Cleared Traditional

Lariat snare

K151197 · United States Endoscopy Group, Inc. · Gastroenterology & Urology
Jul 2015
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K151197 is an FDA 510(k) clearance for the Lariat snare, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 6, 2015, 62 days after receiving the submission on May 5, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K151197 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2015
Decision Date July 06, 2015
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

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

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