510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K840401Substantially Equivalent

Biopsy Needles Various

E-Z-EM, Inc, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840401 is the FDA 510(k) clearance record for BIOPSY NEEDLES VARIOUS, cleared for E-Z-Em, Inc. on . FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K840401.

Clearance record

Decision date
Received
(41 days to decision)
Review panel
Unknown
Applicant
E-Z-Em, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No