510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910653Substantially Equivalent

Touchless II Intermittent Catheter

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

K910653 is the FDA 510(k) clearance record for TOUCHLESS II INTERMITTENT CATHETER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K910653.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation
21 CFR 876.5130
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 FCM

Trailing 12 months
1 clearance under product code FCM in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FCM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260