Cleared Traditional

STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM

K980488 · Storz Instrument Co. · Ophthalmic
Mar 1998
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K980488 is an FDA 510(k) clearance for the STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM, 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 March 23, 1998, 42 days after receiving the submission on February 9, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K980488 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1998
Decision Date March 23, 1998
Days to Decision 42 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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