Cleared Traditional

WILTEK E.R.C.P. CATHETER

K894867 · Wiltek Medical, Inc. · Gastroenterology & Urology
Dec 1989
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K894867 is an FDA 510(k) clearance for the WILTEK E.R.C.P. CATHETER, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 21, 1989, 143 days after receiving the submission on July 31, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K894867 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1989
Decision Date December 21, 1989
Days to Decision 143 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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