Cleared Traditional

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

K862188 · Coburn Optical Ind., Inc. · Ophthalmic
Aug 1986
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K862188 is an FDA 510(k) clearance for the IRRIGATION & ASPIRATION/VITRECTOMY DEVICE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Coburn Optical Ind., Inc. (Clearwater, US). The FDA issued a Cleared decision on August 21, 1986, 73 days after receiving the submission on June 9, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K862188 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1986
Decision Date August 21, 1986
Days to Decision 73 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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