Cleared Traditional

SURGITEK ALL SILICONE INFECTION DOUBJ

K833782 · Surgitek · Gastroenterology & Urology
Apr 1984
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K833782 is an FDA 510(k) clearance for the SURGITEK ALL SILICONE INFECTION DOUBJ, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984, 157 days after receiving the submission on October 28, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K833782 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1983
Decision Date April 02, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAD — Stent, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4620

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