Company · US
Acera Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K261245 | Restrata Acera Surgical, Inc. | QSZ |
| Jun 20, 2025 | K251224 | Restrata Soft Tissue Reinforcement (STR) Acera Surgical, Inc. | OXF |
| May 18, 2023 | K223725 | Restrata® MiniMatrix Acera Surgical, Inc. | QSZ |
| Sep 25, 2020 | K193583 | Restrata® Acera Surgical, Inc. | QSZ |
| Nov 27, 2017 | K172603 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
| Apr 26, 2017 | K170300 | Restrata Wound Matrix Acera Surgical, Inc. | QSZ |
| Aug 8, 2016 | K161278 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
| Mar 16, 2016 | K153613 | Cerafix Dura Substitute Acera Surgical, Inc. | GXQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2022 | Acera Surgical Inc Restrata, Part Number RWM1-2X2 Terminated |
FRO | K170300 K193583 |