510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781736Substantially Equivalent

Disc, Coloplast Pre-Op Stoma

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

K781736 is the FDA 510(k) clearance record for DISC, COLOPLAST PRE-OP STOMA, a class I device, cleared for C.R. Bard, Inc. on under FDA product code EXA (Selector, Size, Ostomy). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K781736.

Clearance record

Decision date
Received
(22 days to decision)
Product code
EXA Selector, Size, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EXA

Trailing 12 months

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

FDA records show no clearances under product code EXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXA, 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