K120735

Substantially Equivalent

PATHASSIT LIGHT SEEKER

Applicant: Entellus Medical, Inc.
Product code: LRC
Advisory panel: Ear, Nose, Throat
Date received: 2012-03-09
Decision date: 2012-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

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.