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
SUBSCRIBE / SIGN IN
K864805Substantially Equivalent

Cloward Surgical Saddle

Surgical Equipment International, Inc., Honolulu HI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864805 is the FDA 510(k) clearance record for CLOWARD SURGICAL SADDLE, cleared for Surgical Equipment International, Inc. on . FDA records list 2 510(k) clearances for Surgical Equipment International, Inc. As of , FDA records show no recalls naming K864805.

Clearance record

Decision date
Received
(15 days to decision)
Review panel
Unknown
Applicant
Surgical Equipment International, Inc. 1670 Halekoa Dr., Honolulu HI
Third party review
No