# Restrata (K261245): 510(k) cleared for Acera Surgical, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261245 |
| Device | Restrata |
| Applicant | Acera Surgical, Inc. |
| Specialty / panel | Other |
| Product code | QSZ |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-10-16 |
| Review time (days) | 183 |
| Third-party review | No |
| Applicant location | St. Louis, MO, US |

## Why this score
- 183-day review, longer than typical.
- Posted 19 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261245). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.