FINESS ENDOSCOPE— 510(k) K102366

Substantially Equivalent

Entellus Medical, Inc.

FDA 510(k) clearance K102366 for FINESS ENDOSCOPE, Substantially Equivalent on 2011-02-15. Applicant: Entellus Medical, Inc..

Clearance details

Applicant: Entellus Medical, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2010-08-20
Decision date: 2011-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.