Acera Surgical, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Restrata Soft Tissue Reinforcement (STR)510(k)Jun 20, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 20, 2025
Restrata® MiniMatrix510(k)May 18, 2023	—	510(k)Substantially Equivalent (Traditional)	May 18, 2023