Cleared Traditional

AUTOMATED INTRAOCULAR SCISSORS

K842471 · Medical Instrument Development Laboratories, Inc. · Ophthalmic
Nov 1984
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K842471 is an FDA 510(k) clearance for the AUTOMATED INTRAOCULAR SCISSORS, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on November 21, 1984, 149 days after receiving the submission on June 25, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K842471 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1984
Decision Date November 21, 1984
Days to Decision 149 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

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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