Cleared Traditional

SYSTEMS PLUS

K860014 · United Surgical Corp. · Ophthalmic
Mar 1986
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K860014 is an FDA 510(k) clearance for the SYSTEMS PLUS, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by United Surgical Corp. (Irvine, US). The FDA issued a Cleared decision on March 5, 1986, 61 days after receiving the submission on January 3, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K860014 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1986
Decision Date March 05, 1986
Days to Decision 61 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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