Cleared Traditional

AN3200 DOUBILET DRAIN

K872458 · H.W. Andersen Products, Inc. · Gastroenterology & Urology
Sep 1987
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K872458 is an FDA 510(k) clearance for the AN3200 DOUBILET DRAIN, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by H.W. Andersen Products, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on September 21, 1987, 90 days after receiving the submission on June 23, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K872458 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1987
Decision Date September 21, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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