Cleared Special

Roth Net Retriever Product Line

K182909 · United States Endoscopy Group, Inc. · Gastroenterology & Urology
Nov 2018
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K182909 is an FDA 510(k) clearance for the Roth Net Retriever Product Line, 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 November 21, 2018, 35 days after receiving the submission on October 17, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K182909 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2018
Decision Date November 21, 2018
Days to Decision 35 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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