Cleared Traditional

KARL STORZ 3D VIDEO SYSTEM

K001362 · Karl Storz Imaging, Inc. · General & Plastic Surgery
Jul 2000
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K001362 is an FDA 510(k) clearance for the KARL STORZ 3D VIDEO SYSTEM, a Laryngoscope, Endoscope (Class II — Special Controls, product code GCI), submitted by Karl Storz Imaging, Inc. (Goleta, US). The FDA issued a Cleared decision on July 17, 2000, 80 days after receiving the submission on April 28, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K001362 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2000
Decision Date July 17, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GCI — Laryngoscope, Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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