Cleared Traditional

DREYER CURVED ENDOILLUMINATOR

K884556 · Advanced Surgical Products, Inc. · Ophthalmic
Feb 1989
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K884556 is an FDA 510(k) clearance for the DREYER CURVED ENDOILLUMINATOR, 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 February 28, 1989, 120 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 K884556 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1988
Decision Date February 28, 1989
Days to Decision 120 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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