Clear Guide SCENERGY— 510(k) K153004

Substantially Equivalent

Clear Guide Medical

FDA 510(k) clearance K153004 for Clear Guide SCENERGY, Substantially Equivalent on 2016-02-12. Applicant: Clear Guide Medical.

Clearance details

Applicant: Clear Guide Medical
Product code: Code JAK
Advisory panel: Radiology
Date received: 2015-10-13
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.