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
K823362Substantially Equivalent

Endomed 433

Kipp & Zonen, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823362 is the FDA 510(k) clearance record for ENDOMED 433, cleared for Kipp & Zonen on . FDA records list one 510(k) clearance for Kipp & Zonen. As of , FDA records show no recalls naming K823362.

Clearance record

Decision date
Received
(120 days to decision)
Review panel
Unknown
Applicant
Kipp & Zonen 803 N. Front St. Suite 3, Mchenry IL
Third party review
No