510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962178Substantially Equivalent

Bard Tiger Guidewire Model 000540

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

K962178 is the FDA 510(k) clearance record for BARD TIGER GUIDEWIRE MODEL 000540, a class II device, cleared for C.R. Bard, Inc. on under FDA product code OCY (Endoscopic Guidewire, Gastroenterology-Urology). FDA's definition for product code OCY reads: "To provide access to gi or gu tract for the purpose of passing or exchanging other accessories". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K962178.

Clearance record

Decision date
Received
(145 days to decision)
Product code
OCY Endoscopic Guidewire, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 129 Concord Rd., Billerica MA
510(k) summary
Summary
Third party review
No

Clearances, product code OCY

Trailing 12 months

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

FDA records show no clearances under product code OCY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260