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
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K802851Substantially Equivalent

Gardner Kuphosis Distractor

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

K802851 is the FDA 510(k) clearance record for GARDNER KUPHOSIS DISTRACTOR, 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 K802851.

Clearance record

Decision date
Received
(97 days to decision)
Review panel
Unknown
Applicant
Downs Surgical , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No