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
K842912Substantially Equivalent

The Suturer

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

K842912 is the FDA 510(k) clearance record for THE SUTURER, cleared for Vlm Surgical, Inc. on . FDA records list 2 510(k) clearances for Vlm Surgical, Inc., from to . As of , FDA records show no recalls naming K842912.

Clearance record

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