ECLERIS SINUSCOPE— 510(k) K131323

Substantially Equivalent

Ecleris USA

FDA 510(k) clearance K131323 for ECLERIS SINUSCOPE, Substantially Equivalent on 2014-06-09. Applicant: Ecleris USA.

Clearance details

Applicant: Ecleris USA
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2013-05-08
Decision date: 2014-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, 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.