Cleared Special

Lariat, Hot/Cold Snare

K200745 · United States Endoscopy Group, Inc. · Gastroenterology & Urology
Apr 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K200745 is an FDA 510(k) clearance for the Lariat, Hot/Cold 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 April 21, 2020, 29 days after receiving the submission on March 23, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K200745 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2020
Decision Date April 21, 2020
Days to Decision 29 days
Submission Type Special
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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