Cleared Traditional

CHARLES PNEUMATIC INTRAOCULAR SCISSORS

K801850 · Cooper Medical Devices Corp. · Ophthalmic
Sep 1980
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K801850 is an FDA 510(k) clearance for the CHARLES PNEUMATIC INTRAOCULAR SCISSORS, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Cooper Medical Devices Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 43 days after receiving the submission on August 4, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K801850 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1980
Decision Date September 16, 1980
Days to Decision 43 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

Similar Devices — HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 148
UniVit HE, UniVit UHS
K212763 · Visioncare Devices, LLC · Aug 2022
Cetus system, Cetus probe
K170183 · A.R.C Laser GmbH · Sep 2017
Bi-Blade Vitrectomy Cutter
K153168 · Medical Instrument Development Laboratories · Apr 2016
CONSTELLATION VISION SYSTEM
K141065 · Alcon Research, Ltd. · Aug 2014
VERSAVIT
K121675 · Synergetics, Inc. · Jun 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · Visioncare Devices, Inc. · May 2012