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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K844072Substantially Equivalent

Dermizip Skin Closure Device

Kells Medical, Inc., Burr Ridge IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844072 is the FDA 510(k) clearance record for DERMIZIP SKIN CLOSURE DEVICE, cleared for Kells Medical, Inc. on . FDA records list 12 510(k) clearances for Kells Medical, Inc., from to . As of , FDA records show no recalls naming K844072.

Clearance record

Decision date
Received
(18 days to decision)
Review panel
Unknown
Applicant
Kells Medical, Inc. 136 Shore Dr., Burr Ridge IL
Third party review
No