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
SUBSCRIBE / SIGN IN
K861954Substantially Equivalent

Hexagonal Wrenches

Med-Tool, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861954 is the FDA 510(k) clearance record for HEXAGONAL WRENCHES, cleared for Med-Tool, Inc. on . FDA records list 28 510(k) clearances for Med-Tool, Inc., from to . As of , FDA records show no recalls naming K861954.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Med-Tool, Inc. 12434 Matthews Ln., St. Louis MO
Third party review
No