Endoform Restella
510(k) K183398
Endoform Restella is a Class II device made by Aroa Biosurgery Ltd., cleared under FDA 510(k) K183398 on 11 Apr 2019, 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 | NumberK183398 | Date11 Apr 2019 | StatusActive |
Official records
- FDA 510(k) database K183398
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- Withdrawn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 K183398
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® PRS R20143-0820P | R20143-0820P / R20143-0820P | 00856072005050 | Length 8.5 cm; Width 20 cm | On the market |
| OviTex® PRS R20143-2020P | R20143-2020P | 00856072005074 | Length 20 cm; Width 20.5 cm | On the market |
| OviTex® PRS R20152-1620G | R20152-1620G | 00856072005005 | Length 16.5 cm; Width 20 cm | On the market |
| OviTex® PRS R20152-2020G | R20152-2020G | 00856072005012 | Length 20 cm; Width 20.5 cm | On the market |
| OviTex® PRS R20243-1018P | R20243-1018P | 00856072005135 | Length 10 cm; Width 18.5 cm | On the market |
| OviTex® PRS R20243-1122P | R20243-1122P | 00856072005142 | Length 11 cm; Width 22 cm | On the market |
| OviTex® PRS R20252-0815G | R20252-0815G | 00856072005029 | Length 8 cm; Width 15 cm | On the market |
| OviTex® PRS R20252-1020G | R20252-1020G | 00856072005289 | Length 10.5 cm; Width 20 cm | On the market |
| OviTex® PRS R20252-1122G | R20252-1122G | 00856072005036 | Length 11.5 cm; Width 22 cm | On the market |
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