510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910196Substantially Equivalent

Bard Hydrogel-Coated Diagnostic Urethral Catheters

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

K910196 is the FDA 510(k) clearance record for BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FGH (Catheter, Double Lumen Female Urethrographic). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K910196.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FGH Catheter, Double Lumen Female Urethrographic
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
Third party review
No

Clearances, product code FGH

Trailing 12 months

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

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