510(k) K183398— Endoform Restella

Substantially Equivalent

Aroa Biosurgery , Ltd.

Clearance details

Applicant: Aroa Biosurgery , Ltd.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2018-12-07
Decision date: 2019-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mangere, NZ

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.