Cleared Traditional

I/A HANDPIECE

K896754 · Advanced Surgical Products, Inc. · Ophthalmic
Jan 1990
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K896754 is an FDA 510(k) clearance for the I/A HANDPIECE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on January 11, 1990, 42 days after receiving the submission on November 30, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K896754 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1989
Decision Date January 11, 1990
Days to Decision 42 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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