510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904779Substantially Equivalent

Button Replacement Gastrostomy Device

C.R. Bard Inc, Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904779 is the FDA 510(k) clearance record for BUTTON REPLACEMENT GASTROSTOMY DEVICE, a class II device, cleared for C.R. Bard, Inc. on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show 5 recalls naming K904779.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. One Park W., Tewksbury MA
Third party review
No

Clearances, product code KGC

Trailing 12 months

FDA records hold no clearances under product code KGC in the trailing twelve months.

FDA records show no clearances under product code KGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260