510(k) clearance

Restrata

FDA 510(k) source

510(k) number

K261245

Applicant

Acera Surgical, Inc.

Decision date

Oct 16, 2026

Date received

Apr 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QSZ

Device type

Absorbable Synthetic Wound Dressing

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

St. Louis, MO, US