Myriad Particles— 510(k) K200502

Substantially Equivalent

Aroa Biosurgery , Ltd.

FDA 510(k) clearance K200502 for Myriad Particles, Substantially Equivalent on 2021-03-31. Applicant: Aroa Biosurgery , Ltd..

Clearance details

Applicant: Aroa Biosurgery , Ltd.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2020-02-28
Decision date: 2021-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mangere, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.