Product code FTL
- Device name
- Mesh, Surgical, Polymeric
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990028S007 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corp. | 2003-12-04 |
| P990028S006 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corp. | 2003-02-04 |
| P990028S005 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corp. | 2002-11-25 |
| P990028S002 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corp. | 2001-07-16 |
| P990028S001 | FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT | Genzyme Corp. | 2001-04-20 |
Related 510(k) Records#
| 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 |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | 2022-09-22 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-08-26 |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Sofradim Production | 2022-06-22 |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | 2022-03-18 |
| K211563 | Pitch-Patchs | Xiros, Ltd. | 2021-08-13 |
| K200918 | SurgiWrap FROST | Mast Biosurgery | 2021-01-07 |
| K201143 | VICRYL Mesh | ETHICON, Inc. | 2020-08-06 |
| K200818 | 3DMax MID Anatomical Mesh | C.R. Bard, Inc. | 2020-07-17 |
| K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | Medtronic, Inc. | 2020-04-08 |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020-03-30 |
| K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | 2020-03-27 |
| K192443 | Dextile Anatomical Mesh | Sofradim Production | 2019-12-06 |
| K191373 | VICRYL Mesh | ETHICON, Inc. | 2019-10-22 |
| K192112 | FlexBand Plus | International Life Sciences | 2019-09-27 |
| K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | 2019-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08903837165978 | Surgical Mesh | HEALTHIUM MEDTECH LIMITED | 2023-08-31 |
| 09421905067539 | OviTex® LPR | AROA BIOSURGERY LIMITED | 2020-03-13 |
| 09421905067157 | Ovitex® PRS | AROA BIOSURGERY LIMITED | 2019-11-14 |
| 09421905067010 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067225 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067201 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067188 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067133 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067119 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067058 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067034 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421904065994 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421904065970 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421904065949 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421904065956 | Restella | AROA BIOSURGERY LIMITED | 2019-04-30 |
| 09421905067423 | Endoform Myriad | AROA BIOSURGERY LIMITED | 2019-03-31 |
| 09421905067416 | Endoform Myriad | AROA BIOSURGERY LIMITED | 2019-03-31 |
| 09421905067409 | Endoform Myriad | AROA BIOSURGERY LIMITED | 2019-03-31 |
| 09421905067317 | Endoform Myriad | AROA BIOSURGERY LIMITED | 2019-03-31 |
| 09421905067393 | Endoform Myriad | AROA BIOSURGERY LIMITED | 2019-03-31 |
| 09421904065703 | OviTex® Core | AROA BIOSURGERY LIMITED | 2018-12-13 |
| 09421904065802 | OviTex LPR Reinforced Bioscaffold | AROA BIOSURGERY LIMITED | 2018-10-26 |
| 09421904065789 | OviTex LPR Reinforced Bioscaffold | AROA BIOSURGERY LIMITED | 2018-10-26 |
| 09421904065765 | OviTex® LPR | AROA BIOSURGERY LIMITED | 2018-10-26 |
| 09421904065024 | OviTex® Core | AROA BIOSURGERY LIMITED | 2016-09-24 |
| 08964050272041 | SurgiWrap® | MAST BIOSURGERY USA INC. | 2015-10-23 |
| 08964050272065 | SurgiWrap® | MAST BIOSURGERY USA INC. | 2015-10-23 |
| 08964050275066 | SurgiWrap® | MAST BIOSURGERY USA INC. | 2015-10-23 |
| 08964050472014 | OrthoWrap® | MAST BIOSURGERY USA INC. | 2015-10-23 |
| 08964050475015 | OrthoWrap® | MAST BIOSURGERY USA INC. | 2015-10-23 |