KYG · Class I · 21 CFR 886.4360

FDA Product Code KYG: Device, Irrigation, Ocular Surgery

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

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 May 19, 1998
SOVEREIGN CATARACT EXTRACTION SYSTEM
K981116
Allergan, Inc.
Ophthalmic · 53d
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 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