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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K861161Substantially Equivalent

Surgi-Tie Loops

Healthmed Corp., Fairport NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861161 is the FDA 510(k) clearance record for SURGI-TIE LOOPS, cleared for Healthmed Corp. on . FDA records list 2 510(k) clearances for Healthmed Corp., from to . As of , FDA records show no recalls naming K861161.

Clearance record

Decision date
Received
(74 days to decision)
Review panel
Unknown
Applicant
Healthmed Corp. 2815 Baird Rd., Fairport NY
Third party review
No