Cleared Special

3DMax Light Mesh

K241250 · Davol Inc., Subsidiary of C. R. Bard, Inc. · General & Plastic Surgery

Jun 2024

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K241250 is an FDA 510(k) clearance for the 3DMax Light Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Davol Inc., Subsidiary of C. R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on June 14, 2024, 42 days after receiving the submission on May 3, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K241250 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2024
Decision Date	June 14, 2024
Days to Decision	42 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF