510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K914567Substantially Equivalent

Cordis Bipal Biopsy Forceps

Cordis US Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914567 is the FDA 510(k) clearance record for CORDIS BIPAL BIOPSY FORCEPS, a class II device, cleared for Cordis Corp. on under FDA product code DWZ (Device, Biopsy, Endomyocardial). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K914567.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DWZ Device, Biopsy, Endomyocardial
Regulation
21 CFR 870.4075
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Statement
Third party review
No

Clearances, product code DWZ

Trailing 12 months

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

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