Auryon Atherectomy System— 510(k) K260244
Substantially EquivalentEximo Medical
FDA 510(k) clearance K260244 for Auryon Atherectomy System, Substantially Equivalent on 2026-04-10. Applicant: Eximo Medical. Device class: 2.
Summary
The Auryon Atherectomy System is a laser atherectomy device for peripheral artery disease, filed under MCW, peripheral atherectomy catheters. Eximo Medical developed Auryon and was later acquired by AngioDynamics, which sells it.
Class II, 21 CFR 870.4875. The Cardiovascular panel reviewed it as a Traditional 510(k).
Eximo Medical filed from Rehovot, Israel. Review took 73 days (January 27 to April 10, 2026). That's quick for a cardiovascular device, and fits an update to a system that has been on the market for several years.
Clearance details
- Applicant
- Eximo Medical
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code MCW
view all- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K242757 — Rotarex Atherectomy System
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . 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.