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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K830522Substantially Equivalent

Stainless Steel Suture 316L

Sharpoint, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830522 is the FDA 510(k) clearance record for STAINLESS STEEL SUTURE 316L, cleared for Sharpoint, Inc. on . FDA records list 9 510(k) clearances for Sharpoint, Inc., from to . As of , FDA records show no recalls naming K830522.

Clearance record

Decision date
Received
(42 days to decision)
Review panel
Unknown
Applicant
Sharpoint, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No