OSIRIS— 510(k) K981153

Substantially Equivalent

Huestis Medical

FDA 510(k) clearance K981153 for OSIRIS, Substantially Equivalent on 1999-03-17. Applicant: Huestis Medical.

Clearance details

Applicant: Huestis Medical
Product code: Code IYE
Advisory panel: Radiology
Date received: 1998-03-30
Decision date: 1999-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.