Identifiers
- 510(k) Number
- K193583 FDA 510(k)
- FDA Product Code
- QSZ FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Restrata® by Acera Surgical Inc — U — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193583 | U | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acera Surgical Inc
- FDA Applicant
- Acera Surgical, Inc.
Sources (1)
- FDA 510(k) K193583 24 fields · synced Jun 18, 2026