510(k) K101519
- Device
- PARIETEX PLUG AND PATCH
- Applicant
- SOFRADIM PRODUCTION
- 510(k) number
- K101519
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-05
- Date received
- 2010-06-02
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Polymeric
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES MCMAHON
- Address
- 15 Crosby Dr. Bedford MA US 01730 01730
FDA Registration Numbers#
- 1614993
- 3024021261
- 2024311
- 1423537
- 1061771
- 2029275
- 2024024
- 2528981
- 3002807523
- 3003936139
- 3031978586
- 3027616027
- 3007321028
- 3005636544
- 3015194982
- 8010177
- 3009749957
- 3007663067
- 3006121828
- 3016248634
- 3017196117
- 1047843
- 2032112
- 9616088
- 3018094310
- 2011171
- 3022140316
- 3010331645
- 1048735
- 3020983460
- 1319639
- 1018233
- 2530154
- 1835959
- 2182208
- 1018470
- 2031966
- 3009756327
- 1064858
- 3013111980
- 9614846
- 3015860534
- 3013188547
- 3014479313
- 3010673515
- 3015231789
- 2219920
- 3008812560
- 8020712
- 8044102
- 3017102971
- 2435947
- 9617465
- 2124215
- 1422634
- 3009417901
- 3004111573
- 3039256597
- 3002294946
- 3003910212
- 3015453963
- 3009380063
- 3004661493
- 1221934
- 3009337401
- 1061124
- 1526534
- 1221051
- 3007109793
- 3010383847
- 1017294
- 3010291427
- 1220246
- 1226146
- 3002807315
- 3033302333
- 2132588
- 3016678045
- 3011582224
- 3002807561
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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