ENDOSCOPE REPROCESSOR OER-PRO— 510(k) K093106

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K093106 for ENDOSCOPE REPROCESSOR OER-PRO, Substantially Equivalent on 2010-02-12. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-01
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.