Endoform Reconstructive Template - PLGA— 510(k) K250598

Substantially Equivalent

Aroa Biosurgery , Ltd.

FDA 510(k) clearance K250598 for Endoform Reconstructive Template - PLGA, Substantially Equivalent on 2025-06-03. Applicant: Aroa Biosurgery , Ltd..

Clearance details

Applicant: Aroa Biosurgery , Ltd.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2025-02-28
Decision date: 2025-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.