3DMax Light Mesh
FDA 510(k) clearance K241250 · decided 2024-06-14
Clearance details
- K-number
- K241250
- Device name
- 3DMax Light Mesh
- Applicant
- Davol Inc., Subsidiary of C. R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-03
- Decision date
- 2024-06-14
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warwick, RI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956) | Sofradim Production | 2026-05-21 |
| Parietene™ Flat Sheet Mesh (K253125) | Medtronic - Sofradim Production | 2025-10-24 |
| Onflex™ Mesh (K251955) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Parietene™ Macroporous Mesh (PPM5050 ) (K250869) | Sofradim Production | 2025-04-23 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| ProGrip™ Self-Gripping Polypropylene Mesh (K243315) | Sofradim Production | 2025-01-17 |
| Progrip™ Self-Gripping Polypropylene Mesh (K232373) | Sofradim Production | 2024-01-18 |
| Bard 3DMax Mesh (K233402) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| T-Line® Hernia Mesh (K232924) | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| Pitch PaSoft Tissue Reinforcement Device (K230671) | Xiros, Ltd. | 2023-05-31 |
| T-Line Hernia Mesh (K230227) | Deep Blue Medical Advances, Inc. | 2023-02-23 |
Recalls involving this device
No recalls on record reference this clearance.