OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1— 510(k) K000948

Substantially Equivalent

Keymed (Medical & Industrial Equipment), Ltd.

FDA 510(k) clearance K000948 for OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1, Substantially Equivalent on 2000-05-12. Applicant: Keymed (Medical & Industrial Equipment), Ltd..

Clearance details

Applicant: Keymed (Medical & Industrial Equipment), Ltd.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2000-03-23
Decision date: 2000-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southend-On-Sea, Essex, GB

Download summary PDF View on FDA.gov ↗

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.