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

Bag, Intestine

21 CFR 878.4100 / General, Plastic Surgery
FDA source (opens on fda.gov)

KGY is the FDA product code for Bag, Intestine, a class I device type, regulated under 21 CFR 878.4100. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KGY
Device name
Bag, Intestine
Regulation
21 CFR 878.4100
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code KGY

By decision year
6 clearances under product code KGY with a decision year between 1980 and 1993, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KGY by decision year
YearClearances
19802
19831
19912
19931

Applicants with the most clearances

Product code KGY
Applicants holding the most 510(k) clearances under product code KGY
ApplicantClearances
Johnson & Johnson Professionals, Inc.2
3M Company1
Cook Incorporated1
Medovations, Inc.1
Megadyne Medical Products, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order