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
K820682Substantially Equivalent

Surgical Instruments

Intl. Needle, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820682 is the FDA 510(k) clearance record for SURGICAL INSTRUMENTS, cleared for Intl. Needle, Inc. on . FDA records list one 510(k) clearance for Intl. Needle, Inc. As of , FDA records show no recalls naming K820682.

Clearance record

Decision date
Received
(34 days to decision)
Review panel
Unknown
Applicant
Intl. Needle, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No