Cleared Traditional

ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE

K884557 · Advanced Surgical Products, Inc. · Ophthalmic
May 1989
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K884557 is an FDA 510(k) clearance for the ADVANCED SURGICAL PRODUCTS SCISSORS 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 May 12, 1989, 193 days after receiving the submission on October 31, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K884557 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1988
Decision Date May 12, 1989
Days to Decision 193 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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