510(k) K241250

3DMax Light Mesh by Davol Inc., Subsidiary of C. R. Bard, Inc. — Product Code FTL

K241250 is an FDA 510(k) premarket notification submitted by Davol Inc., Subsidiary of C. R. Bard, Inc. for the device "3DMax Light Mesh". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol Inc., Subsidiary of C. R. Bard, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2024
Date Received
May 3, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type