Cleared Traditional

STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE

K960061 · Storz Instrument Co. · Ophthalmic
Sep 1996
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K960061 is an FDA 510(k) clearance for the STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 18, 1996, 258 days after receiving the submission on January 4, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K960061 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1996
Decision Date September 18, 1996
Days to Decision 258 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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