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

Tube, Gastro-Enterostomy

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KGC is the FDA product code for Tube, Gastro-Enterostomy, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 25 recalls.

Classification record

Product code
KGC
Device name
Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
26
Ingested recalls
25

Clearances, product code KGC

By decision year
26 clearances under product code KGC with a decision year between 1978 and 2025, 1990 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code KGC by decision year
YearClearances
19781
19861
19891
19907
19914
19981
20082
20091
20121
20171
20193
20201
20231
20251

Applicants with the most clearances

Product code KGC
Applicants holding the most 510(k) clearances under product code KGC
ApplicantClearances
Applied Medical Technologies3
Applied Medical Technology Inc3
CoapTech, Inc.3
C.R. Bard Inc2
Cook Incorporated2
Kimberly-Clark Corporation2
Southside Biotechnology2
Argon Medical Corp.1
Corpak Co.1
Fidmi Medical, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order