510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910492Substantially Equivalent

Bard Replacement Gastrostomy Tube

C.R. Bard Inc, Murray Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910492 is the FDA 510(k) clearance record for BARD REPLACEMENT GASTROSTOMY TUBE, 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 4 recalls naming K910492.

Clearance record

Decision date
Received
(169 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. 111 Spring St., Murray Hill NJ
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