CITATION SINUSCOPE— 510(k) K951249

Substantially Equivalent

Citation Medical Corp.

FDA 510(k) clearance K951249 for CITATION SINUSCOPE, Substantially Equivalent on 1995-04-10. Applicant: Citation Medical Corp..

Clearance details

Applicant: Citation Medical Corp.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-20
Decision date: 1995-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.