Endoform Reconstructive Template - Non Absorbable
510(k) K181935
Endoform Reconstructive Template - Non Absorbable is a Class II device made by Aroa Biosurgery Ltd., cleared under FDA 510(k) K181935 on 4 Dec 2018, 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 | NumberK181935 | Date4 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K181935
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTL
- 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 K181935
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 F10246-2530P | F10246-2530P | 09421904065727 | — | On the market |
| OviTex® 1S F10246-2540P | F10246-2540P | 09421904065734 | — | On the market |
| OviTex® 2S F10248-2530P | F10248-2530P | 09421904065741 | — | On the market |
| OviTex® 2S F10248-2540P | F10248-2540P | 09421904065758 | — | On the market |
| OviTex® Core F10244-2530P | F10244-2530P | 09421904065703 | — | On the market |
| OviTex® Core F10244-2540P | F10244-2540P | 09421904065710 | — | On the market |
Similar devices
Other devices filed under FDA product code FTL (Mesh, Surgical, Polymeric).
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- WITTMANN PATCH by Aperta, LLC
- ORTHOMEND by TEI BIOSCIENCES INC.
- TYRX ANTIMICROBIAL MESH by Tyrx Pharma, Inc.
- VITAMESH MACROPOROUS PP SURGICAL MESH by Proxy Biomedical, Ltd.
- INCLOSE SURGICAL MESH SYSTEM by Anulex Technologies, Inc.
- BARD COMPOSITE L/P MESH by Davol Inc., Sub. C. R. Bard, Inc.
- GORE-TEX MYCROMESH PLUS BIOMATERIAL by W. L. Gore & Associates, Inc.