510(k) K221280

Vesseal by Lydus Medical , Ltd. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2022
Date Received
May 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type