Acera Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Acera Surgical, Inc.” (first 2016, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 89 days, against 106 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 92 |
| 2017 | 2 | 87 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 277 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 156 |
| 2024 | 0 | — |
| 2025 | 1 | 60 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acera Surgical, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXQ | Dura Substitute | 3 | 3 |
| QSZ | Absorbable Synthetic Wound Dressing | 3 | 3 |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 1 | 1 |
Review panels
Most recent Acera Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | OXF | 2025-06-20 | 60 |
| K223725 | Restrata® MiniMatrix | QSZ | 2023-05-18 | 156 |
| K193583 | Restrata® | QSZ | 2020-09-25 | 277 |
| K172603 | Cerafix Dura Substitute | GXQ | 2017-11-27 | 89 |
| K170300 | Restrata Wound Matrix | QSZ | 2017-04-26 | 85 |
| K161278 | Cerafix Dura Substitute | GXQ | 2016-08-08 | 94 |
| K153613 | Cerafix Dura Substitute | GXQ | 2016-03-16 | 90 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-03-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Acera Surgical, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06578650: A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms (Recruiting, started 2024-10-31)
- NCT04918784: Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (Completed, started 2021-05-05)
- NCT03312595: Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) (Completed, started 2017-09-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acera Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Acera Surgical, Inc.” (first 2016, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acera Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acera Surgical, Inc. is 90 days. Since 2017: 89 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acera Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GXQ (Dura Substitute, 3); QSZ (Absorbable Synthetic Wound Dressing, 3); OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery, 1).
Next steps
- See all 7 Acera Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXQ, Acera Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.