Cleared Traditional

FLEXIBLE SNARE

K902265 · Annex Medical, Inc. · Gastroenterology & Urology
Jul 1990
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K902265 is an FDA 510(k) clearance for the FLEXIBLE SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 27, 1990, 67 days after receiving the submission on May 21, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K902265 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1990
Decision Date July 27, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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

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