510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KYGClass I

Device, Irrigation, Ocular Surgery

21 CFR 886.4360 / Ophthalmic
FDA source (opens on fda.gov)

KYG is the FDA product code for Device, Irrigation, Ocular Surgery, a class I device type, regulated under 21 CFR 886.4360. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
KYG
Device name
Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
40
Ingested recalls
11

Clearances, product code KYG

By decision year
40 clearances under product code KYG with a decision year between 1976 and 2001, 1992 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KYG by decision year
YearClearances
19761
19802
19822
19833
19841
19852
19863
19871
19884
19901
19926
19931
19943
19951
19961
19972
19983
19991
20001
20011

Applicants with the most clearances

Product code KYG
Applicants holding the most 510(k) clearances under product code KYG
ApplicantClearances
Visitec Co.3
B&B Medical Assoc., Inc.2
JEDMED Instrument Company2
Med-logics Inc2
Mortan, Inc.2
Optical Micro Systems, Inc.2
Site Microsurgical Systems, Inc.2
Surgeon Surgical Instrumentation, Inc.2
Alcon Laboratories1
Allergan1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 74 companies shown, in name order