Cleared Traditional

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

K904797 · Surgitek · Gastroenterology & Urology
Mar 1991
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K904797 is an FDA 510(k) clearance for the SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16), a Cystourethroscope (Class II — Special Controls, product code FBO), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 5, 1991, 133 days after receiving the submission on October 23, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K904797 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1990
Decision Date March 05, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FBO — Cystourethroscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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