Data / Medical devices / United States / Acera Surgical - Adie Road
Acera Surgical - Adie Road: FDA-registered device maker in Maryland Heights, MO, United States, 1 510(k) clearance
Acera Surgical - Adie Road is registered with the FDA (registration 3027386220) in Maryland Heights, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 18, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027386220
- Address
- 11825 Adie Road, Maryland Heights, MO, United States, 63043
- Owner or operator
- Acera Surgical, Inc. (10051479)
- Roles
- Manufacturer
- First device listed
- May 26, 2023
- Registered through
- 2026
- Brand names listed
- Restrata MiniMatrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2023 | K223725 | Restrata® MiniMatrix | QSZ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.