510(k) K212355— Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

Substantially Equivalent

Checkpoint Surgical

Clearance details

Applicant: Checkpoint Surgical
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2021-07-29
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Independence, OH, US

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.