510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K841125Substantially Equivalent

Hucksteps Staples

Downs Surgical, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841125 is the FDA 510(k) clearance record for HUCKSTEPS STAPLES, cleared for Downs Surgical , Ltd. on . FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K841125.

Clearance record

Decision date
Received
(69 days to decision)
Review panel
Unknown
Applicant
Downs Surgical , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No