510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920342Substantially Equivalent

Bard Stone Removal Balloon Catheter

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

K920342 is the FDA 510(k) clearance record for BARD STONE REMOVAL BALLOON CATHETER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K920342.

Clearance record

Decision date
Received
(212 days to decision)
Product code
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. One Park W., Tewksbury MA
510(k) summary
Summary
Third party review
No

Clearances, product code GCA

Trailing 12 months
1 clearance under product code GCA 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 GCA, 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