Cleared Traditional

VERSAVIT

K121675 · Synergetics, Inc. · Ophthalmic
Jun 2012
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K121675 is an FDA 510(k) clearance for the VERSAVIT, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on June 21, 2012, 15 days after receiving the submission on June 6, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K121675 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2012
Decision Date June 21, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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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