510(k) K141394
- Device
- X-REPAIR
- Applicant
- SYNTHASOME
- 510(k) number
- K141394
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-06
- Date received
- 2014-05-28
- 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
- No
Applicant Contact#
- Contact
- ANTHONY RATCLIFFE
- Address
- 3030 Bunker Hill St., Suite 308 San Diego CA US 92109 92109
FDA Registration Numbers#
- 3027616027
- 3014461810
- 3005987240
- 2435947
- 3003910212
- 3004464325
- 2530154
- 1018470
- 3002807295
- 1048735
- 3016678045
- 8043484
- 3002806603
- 3009217531
- 3006082230
- 3003418325
- 3027699572
- 1221934
- 3009380063
- 1064584
- 3005953126
- 9615742
- 3002807561
- 3020983460
- 3006121828
- 3009756327
- 3015194982
- 2210968
- 8043734
- 2011171
- 1835959
- 3005636544
- 3013188547
- 3017210488
- 2031093
- 1221051
- 8020712
- 3030733800
- 1061124
- 3015231789
- 3002807310
- 3017102971
- 2024024
- 3015453963
- 2528981
- 3010187263
- 3005619880
- 3024021261
- 8010177
- 3010237768
- 1017294
- 2132588
- 3004111573
- 9617465
- 3005941719
- 3015860534
- 3009417901
- 3003936139
- 3007663067
- 3002294946
- 3022140316
- 3018094310
- 1526534
- 2029275
- 9614846
- 3007156625
- 3009514842
- 3033273526
- 1213643
- 3014272734
- 1064858
- 3010178296
- 3030412764
- 1061771
- 1047843
- 3009420598
- 1000393132
- 3019101334
- 3011989923
- 2028924
Source Documents#
Other 510(k) Records For Product Code FTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | 2026-05-21 |
| 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 |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | 2025-06-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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