Cleared Traditional

K883760 - STORZ MODEL 62 ENT CAMERA SYSTEM
(FDA 510(k) Clearance)

K883760 · Storz Instrument Co. · General & Plastic Surgery
Sep 1988
Decision
22d
Days
Class 1
Risk

K883760 is an FDA 510(k) clearance for the STORZ MODEL 62 ENT CAMERA SYSTEM. This device is classified as a Camera, Cine, Endoscopic, Without Audio (Class I — General Controls, product code FWL).

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 28, 1988, 22 days after receiving the submission on September 6, 1988.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.

Submission Details

510(k) Number K883760 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1988
Decision Date September 28, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FWL — Camera, Cine, Endoscopic, Without Audio
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4160