XC11 ICE System, USA— 510(k) K250955

Name: FDA 510(k) clearance K250955
Creator: U.S. Food and Drug Administration
Published: 2025-10-22

Substantially Equivalent

Yorlabs, Inc.

FDA 510(k) clearance K250955 for XC11 ICE System, USA, Substantially Equivalent on 2025-10-22. Applicant: Yorlabs, Inc.. Device class: 2.

Clearance details

Applicant: Yorlabs, Inc.
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
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 ↗

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K261696 — ACUNAV Luxera 4D ICE Catheter2026-09-10
K261849 — VERAFEYE Imaging Catheter (VF-VIC-002)2026-07-24
K252945 — Novasight Hybrid System2026-04-17
K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more2026-04-08
K253399 — Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter2025-10-28

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.