Cleared Traditional

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION

K962393 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology
Sep 1996
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K962393 is an FDA 510(k) clearance for the KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 17, 1996, 89 days after receiving the submission on June 20, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K962393 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1996
Decision Date September 17, 1996
Days to Decision 89 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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