ULYSS Multi View Sinuscope— 510(k) K153701

Substantially Equivalent

Sopro-Comeg GmbH

FDA 510(k) clearance K153701 for ULYSS Multi View Sinuscope, Substantially Equivalent on 2016-09-09. Applicant: Sopro-Comeg GmbH.

Clearance details

Applicant: Sopro-Comeg GmbH
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2015-12-23
Decision date: 2016-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

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.