510(k) K251557
- Device
- Bard® Mesh; Bard® Mesh Pre-Shaped
- Applicant
- Davol, Inc.
- 510(k) number
- K251557
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-12
- Date received
- 2025-05-21
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Polymeric
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Becca DeFrancia
- Address
- 100 Crossings Blvd. Warwick RI US 02886 02886
FDA Registration Numbers
- 3013111980
- 3010034780
- 1649390
- 1061124
- 3032412536
- 3002807315
- 3003936139
- 3011582224
- 3004464325
- 2648650
- 9617465
- 3015453963
- 3010291427
- 3013188547
- 8044102
- 1018470
- 3003910212
- 3009749957
- 3005636544
- 8043484
- 2031093
- 1061771
- 3010131137
- 1423537
- 1721676
- 3017492634
- 1064858
- 3017210488
- 2024024
- 3010513348
- 3017196117
- 1018233
- 3009756327
- 3010237768
- 8010177
- 3006121828
- 3030733800
- 3006174295
- 2435947
- 3010331645
- 1422634
- 3015860534
- 3010187263
- 2530154
- 3015231789
- 3002808022
- 3014279513
- 3039256597
- 3004944585
- 1058584
- 3009217531
- 1835959
- 1226146
- 3030412764
- 3002807310
- 3002807523
- 2031966
- 3007663067
- 3009417901
- 3020983460
- 9614846
- 8020712
- 3009514842
- 1000393132
- 1526534
- 3002807295
- 3027616027
- 1319639
- 9615742
- 3008812560
- 3021632375
- 3010383847
- 3033302333
- 3005953126
- 3002807561
- 1220246
- 3005941719
- 3004661493
- 3022140316
- 3024021261
Source Documents
Other 510(k) Records For Product Code FTL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253125 | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | 2025-10-24 |
| K251955 | Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025-04-23 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | 2025-04-09 |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production | 2025-01-17 |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Sofradim Production | 2024-01-18 |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023-05-31 |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-02-23 |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022-11-28 |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | 2022-09-22 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-08-26 |