Cleared Traditional

SURGITEK INFUSER

K941952 · Surgitek · Gastroenterology & Urology
May 1994
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K941952 is an FDA 510(k) clearance for the SURGITEK INFUSER, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on May 24, 1994, 32 days after receiving the submission on April 22, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K941952 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1994
Decision Date May 24, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

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

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