Endoform Reconstructive Template - PLGA
510(k) K250598
Endoform Reconstructive Template - PLGA is a Class II device made by Aroa Biosurgery Ltd., cleared under FDA 510(k) K250598 on 3 Jun 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250598 | Date3 Jun 2025 | StatusActive |
Official records
- FDA 510(k) database K250598
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTM
- FDA applicant
- Aroa Biosurgery , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250598
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OviTex® 1S F10266-0408G | F10266-0408G | 09421907331935 | — | On the market |
| OviTex® 1S F10266-0610G | F10266-0610G | 09421907331942 | — | On the market |
| OviTex® 1S F10266-1012G | F10266-1012G | 09421907331959 | — | On the market |
| OviTex® 1S F10266-1020G | F10266-1020G | 09421907331966 | — | On the market |
| OviTex® 1S F10266-1620G | F10266-1620G | 09421907331973 | — | On the market |
| OviTex® 1S F10266-2020G | F10266-2020G | 09421907331997 | — | On the market |
| OviTex® 2S F10268-2020G | F10268-2020G | 09421908222065 | — | On the market |
| OviTex® Core F10264-0610G | F10264-0610G | 09421907331874 | — | On the market |
| OviTex® Core F10264-1012G | F10264-1012G | 09421907331881 | — | On the market |
| OviTex® Core F10264-2020G | F10264-2020G | 09421907331928 | — | On the market |
| OviTex® Inguinal F10263-1017I | F10263-1017I | 09421908222140 | — | On the market |
| OviTex® Inguinal F10263-1317I | F10263-1317I | 09421908222157 | — | On the market |
| OviTex® Low Profile F10264-0606L | F10264-0606L | 09421908222263 | — | On the market |
| OviTex® Low Profile F10264-0909L | F10264-0909L | 09421908222072 | — | On the market |
| OviTex® Low Profile F10264-1212L | F10264-1212L | 09421908222089 | — | On the market |
| OviTex® Low Profile F10264-1218L | F10264-1218L | 09421908222102 | — | On the market |
| OviTex® Low Profile F10264-1515L | F10264-1515L | 09421908222096 | — | On the market |
| OviTex® Low Profile F10264-1520L | F10264-1520L | 09421908222119 | — | On the market |
| OviTex® Low Profile F10264-1525L | F10264-1525L | 09421908222126 | — | On the market |
Similar devices
Other devices filed under FDA product code FTM (Mesh, Surgical).
- VersaWrap Tendon Protector by ALAFAIR BIOSCIENCES, INC.
- SURGISIS RVP RECTO-VAGINAL FISTULA PLUG by Cook Biotech, Inc.
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- PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX by Brennen Medical, LLC
- FORTAFLEX SURGICAL SLING by ORGANOGENESIS INC.
- Endoform Reconstructive Template by Aroa Biosurgery Limited (Formerly Mesynthes Limited)
- Miromatrix Biological Mesh TW by Miromatrix Medical, Inc.
- SIS DERMAL AUGMENTATION STRAND by Cook Biotech, Inc.
- SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. by Shelhigh, Inc.