510(k) K100899— OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

Substantially Equivalent

Keymed (Medical & Industrial Equipment), Ltd.

Clearance details

Applicant: Keymed (Medical & Industrial Equipment), Ltd.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2010-03-31
Decision date: 2010-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

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.