Cleared Traditional

ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES

K993103 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology
Dec 1999
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K993103 is an FDA 510(k) clearance for the ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on December 10, 1999, 85 days after receiving the submission on September 16, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K993103 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1999
Decision Date December 10, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code GCM — Endoscope, Rigid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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