KYG · Class I · 21 CFR 886.4360

FDA Product Code KYG: Device, Irrigation, Ocular Surgery

Leading manufacturers include Visitec Co., Jedmed Instrument Co. and Site Microsurgical Systems, Inc..

40
Total
40
Cleared
91d
Avg days
1976
Since

FDA 510(k) Cleared Device, Irrigation, Ocular Surgery Devices (Product Code KYG)

40 devices
1–24 of 40
Cleared Dec 28, 1999
BLADEWORKS DISPOSABLE ALK TUBING
K993591
Blade Works, Inc.
Ophthalmic · 67d
Cleared May 19, 1998
SOVEREIGN CATARACT EXTRACTION SYSTEM
K981116
Allergan, Inc.
Ophthalmic · 53d
Cleared May 15, 1998
EYE IRRIGATOR MODEL #2020
K980647
Eye-Deal Ocular Safety Products, Inc.
Ophthalmic · 87d
Cleared Feb 19, 1998
MOISTAIR FLUID AIR TUBING SET
K974561
American Medical Devices, Inc.
Ophthalmic · 76d
Cleared May 22, 1997
ML DISPOSABLE ALK TUBING
K971173
Med-Logics, Inc.
Ophthalmic · 52d
Cleared Mar 25, 1997
HEDGES CORNEAL WETTING PAK
K970161
Hedges Cwp, Inc.
Ophthalmic · 70d
Cleared Apr 15, 1996
D.O.R.C. VFI/VFE SYSTEM
K954842
Dutch Ophthalmic USA, Inc.
Ophthalmic · 175d
Cleared Feb 08, 1995
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
K945171
Boston Surgical Products, Inc.
Ophthalmic · 110d
Cleared Aug 23, 1994
PEREGRINE PIC MINIPULATOR
K940392
Peregrine Surgical , Ltd.
Ophthalmic · 209d
Cleared Feb 16, 1994
I/V POLE
K935226
Optical Micro Systems, Inc.
Ophthalmic · 107d
Cleared Jan 25, 1994
ELECTRIC I/V POLE OR EIVP2
K935003
Optical Micro Systems, Inc.
Ophthalmic · 98d
Cleared Dec 06, 1993
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921
Site Microsurgical Systems, Inc.
Ophthalmic · 378d
Cleared Jul 27, 1992
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996
Chiron Vision Corp.
Ophthalmic · 35d
Cleared Mar 19, 1992
AQUEOUS PARACENTESIS PIPET
K915808
Visitec Co.
Ophthalmic · 86d
Cleared Nov 21, 1990
SITE DIAPHRAGM CASSETTE
K904186
Site Microsurgical Systems, Inc.
Ophthalmic · 70d
Cleared Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682
Alcon Laboratories
Ophthalmic · 73d
Cleared Apr 04, 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544
Staar Surgical Co.
Ophthalmic · 50d
Cleared Mar 31, 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013
Ameritek, Inc.
Ophthalmic · 13d
Cleared Sep 11, 1985
VISITEC IRRIGATION CONTROL SYSTEM
K853243
Visitec Co.
Ophthalmic · 41d
Cleared Mar 05, 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039
Jedmed Instrument Co.
Ophthalmic · 67d
Cleared Nov 21, 1984
OPERAID NUCLEUS
K841807
Jedmed Instrument Co.
Ophthalmic · 204d
Cleared Oct 04, 1983
ELECATH HEPARIN COATED THERMAL DILUTION
K832787
Electro-Catheter Corp.
Ophthalmic · 49d
Cleared Jul 12, 1983
MICRO SURGICAL HANDLE
K831996
Visitec Co.
Ophthalmic · 21d

About Product Code KYG - Regulatory Context