510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860168Substantially Equivalent

Umi (Franseen,westcott,greene,menghini)bio. Needle

Universal Medical Instrument Corp., Ballston Spa NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860168 is the FDA 510(k) clearance record for UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE, cleared for Universal Medical Instrument Corp. on . FDA records list 21 510(k) clearances for Universal Medical Instrument Corp., from to . As of , FDA records show no recalls naming K860168.

Clearance record

Decision date
Received
(33 days to decision)
Review panel
Unknown
Applicant
Universal Medical Instrument Corp. Post Office Box 100, Ballston Spa NY
Third party review
No