K241250 is an FDA 510(k) clearance for the 3DMax Light Mesh. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K241250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FTL - Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |