XC11 ICE System, USA— 510(k) K250955

Substantially Equivalent

Yorlabs, Inc.

FDA 510(k) clearance K250955 for XC11 ICE System, USA, Substantially Equivalent on 2025-10-22. Applicant: Yorlabs, Inc..

Clearance details

Applicant: Yorlabs, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2025-03-31
Decision date: 2025-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.