Checkpoint, Checkpoint Head & Neck— 510(k) K150005

Substantially Equivalent

Ndi Medical, LLC

FDA 510(k) clearance K150005 for Checkpoint, Checkpoint Head & Neck, Substantially Equivalent on 2015-02-19. Applicant: Ndi Medical, LLC.

Clearance details

Applicant: Ndi Medical, LLC
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-02
Decision date: 2015-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.