OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1— 510(k) K100803

Substantially Equivalent

Keymed, Inc.

FDA 510(k) clearance K100803 for OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1, Substantially Equivalent on 2010-04-22. Applicant: Keymed, Inc..

Clearance details

Applicant: Keymed, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2010-03-22
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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.