Cleared Traditional

KARL STORZ BOUGIES AND DILATORS

K950125 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology
Feb 1995
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K950125 is an FDA 510(k) clearance for the KARL STORZ BOUGIES AND DILATORS, a Bougie, Urological (Class I — General Controls, product code FAX), submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on February 7, 1995, 26 days after receiving the submission on January 12, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5520.

Submission Details

510(k) Number K950125 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1995
Decision Date February 07, 1995
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FAX — Bougie, Urological
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5520

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