Auryon Atherectomy System
Device Facts
| Record ID | K260244 |
|---|---|
| Device Name | Auryon Atherectomy System |
| Applicant | Eximo Medical |
| Product Code | MCW · Cardiovascular |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
Device Story
Laser-based atherectomy system; consists of single-use catheter and laser console. Catheter features optic fiber array surrounded by circumferential blunt blade. Laser delivers short, high-intensity pulses (355 nm) to photoablate stenoses/occlusions. Operates over commercially available guidewire. Used in clinical settings by physicians. Larger catheters (2.0mm, 2.35mm) include aspiration feature for debris/thrombus removal and off-center feature for debulking beyond catheter diameter. System enables vessel recanalization; benefits include improved blood flow and lesion treatment. Modifications include addition of 0.9mm and 1.5mm Rapid Exchange (RX) catheters with hydrophilic coating.
Clinical Evidence
Bench testing only. No clinical data presented. Performance testing included shaft profile, trackability, pushability, kinkability, pull tests, leakage, torque strength, optical functionality, optical durability, and hydrophilic coating evaluation.
Technological Characteristics
Laser atherectomy system; Nd:YAG active medium; 355 nm wavelength; 40 Hz pulse rate; 10-25 ns pulse duration; 50-60 mJ/mm2 fluence. Catheters feature optic fiber array, blunt blade, and optional hydrophilic coating. Radiographic markers: 90% Pt / 10% Ir alloy. Sterilization: Ethylene Oxide. Biocompatibility per ISO 10993.
Indications for Use
Indicated for patients with infra-inguinal arterial stenoses and occlusions, including in-stent restenosis (ISR). Used for atherectomy and thrombus aspiration in native and stented infra-inguinal arteries.
Regulatory Classification
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Predicate Devices
- Auryon™ Atherectomy System (K233668)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 10, 2026
Eximo Medical
Kasey Newcomb
Sr. Manager Regulatory Affairs
Pekeris St. 3
Rehovot, 7670203
Israel
Re: K260244
Trade/Device Name: Auryon™ Atherectomy System
Regulation Number: 21 CFR 870.4875
Regulation Name: Intraluminal Artery Stripper
Regulatory Class: Class II
Product Code: MCW
Dated: January 21, 2026
Received: January 27, 2026
Dear Kasey Newcomb:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260244 - Kasey Newcomb
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K260244 - Kasey Newcomb
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Sincerely,
KRINA M. PATEL -S
Digitally signed by
KRINA M. PATEL -S
Date: 2026.04.10
12:29:14 -04'00'
For,
Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary and
Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260244 | |
| Device Name Auryon™ Atherectomy System | |
| Indications for Use (Describe) The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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510(k) Number: K260244
# 510(K) SUMMARY FOR THE AURYON ATHERECTOMY SYSTEM
## SPONSOR
Eximo Medical Ltd
Pekeris St 3
Rehovot, Israel 7670203
## CONTACT
Kasey Newcomb
Sr. Manager, Global Regulatory Affairs
Eximo Medical Ltd / AngioDynamics, Inc
## DEVICE NAME
Trade Name: Auryon™ Atherectomy System
Common/Usual Name: Peripheral Atherectomy Catheter
Classification Name: Intraluminal Artery Stripper
(21 CFR § 870.4875, Class II, Pro-Code MCW)
Classification Panel: Cardiovascular
## PREDICATE DEVICE
510(k): K233668
Trade Name: Auryon™ Atherectomy System
Common/Usual Name: Peripheral Atherectomy Catheter
Classification Name: Intraluminal Artery Stripper
(21 CFR § 870.4875, Class II, Pro-Code MCW)
Classification Panel: Cardiovascular
## DEVICE DESCRIPTION
The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 mJ/mm2 to the occluded or narrowed artery. The laser delivers very short high intensity pulses which travel from the laser, through the fibers, and emerge from the polished ends of the individual fibers, resulting in the photoablation of infra-inguinal stenoses and occlusions in native and stented infra-inguinal arteries.
The Auryon™ Atherectomy System must work over a commercially available guide wire that crosses the lesion intra-luminally. The catheters are available in nine configurations (0.9mm, 0.9mm XL, 0.9mm RX, 1.5mm, 1.5mm XL, 1.5mm RX, 1.7mm, 2.0mm and 2.35mm), with and without hydrophilic coating configuration available.
For the small size catheters (i.e., 0.9mm, 1.5mm, and 1.7mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. Additionally, the 0.9mm and 1.5mm catheters come in an extra-long length and a rapid exchange configuration where a guidewire port is positioned 45cm from the distal end. The 0.9mm, 1.5mm, and 1.7mm catheters do not have an aspiration feature and have not been tested in ISR lesions.
The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions.
The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
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510(k) Number: K260244
# INDICATION FOR USE
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
# COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed Auryon Atherectomy System is substantially equivalent to the predicate Auryon Atherectomy K233668. Both laser atherectomy devices have identical laser wavelength and pulse parameters. There are no significant differences in the technological characteristics of the proposed device and predicate device which raised different questions of safety and effectiveness. Table 1 below provides a comparison of the subject and predicate device.
Table 1. Subject and Predicate Device Comparison
| Device Comparison | Subject Device Auryon Atherectomy System | Predicate Device Auryon Atherectomy System |
| --- | --- | --- |
| Indication for Use | The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions. | The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions. |
| Active Medium | Nd:YAG | Nd:YAG |
| Laser Wavelength | 355 nm | 355 nm |
| Laser Fluence levels | 50 and 60 mJ/mm2 | 50 and 60 mJ/mm2 |
| Pulse Rate | 40 Hz | 40 Hz |
| Pulse Duration | 10-25 ns | 10-25 ns |
| Maximum output | 33.5 mJ | 33.5 mJ |
| Catheter Configurations | 0.9mm, 0.9mm Extra Long (XL), 0.9mm Rapid Exchange (RX), 1.5 mm, 1.5mm Extra Long (XL), 1.5mm Rapid Exchange (RX), 1.7mm, 2.0mm, 2.35mm | 0.9mm, 0.9mm Extra Long (XL), 1.5 mm, 1.5mm Extra Long (XL), 1.7 mm 2.0mm, 2.35mm |
| Radiographic marker | 90% Pt / 10% Ir alloy tube, size 0.9mm, 0.9mm XL, and 0.9mm RX catheters only | 90% Pt / 10% Ir alloy tube, size 0.9mm and 0.9mm XL only |
| Catheter Sterilization Method | Ethylene Oxide | Ethylene Oxide |
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510(k) Number: K260244
## DEVICE MODIFICATIONS AND RISK ASSOCIATED WITH THE DESIGN MODIFICATION(S)
Modifications made to the Auryon Atherectomy System were limited to introducing of the 0.9mm and 1.5mm Rapid Exchange Auryon Atherectomy Catheters with hydrophilic coating. There is no change to the principles of operations, intended purpose, technology characteristics, between the proposed system and the predicate.
The impact of the change as described within this submission were evaluated a part of the Risk analysis activity in terms of new/existing risks and new/existing failure modes. The results of this Risk Analysis activity were compared to the current risk Analysis; the conclusion drawn from this assessment determined that the additional catheters did not impact or modify an existing risk no necessitate a new or modified risk.
## COMPARISON OF PERFORMANCE DATA
The 0.9mm and 1.5mm Rapid Exchange Auryon Atherectomy Catheters were tested using the same methods and acceptance criteria as was done within the predicate device. Specific tests are listed below:
- Shaft Outer and Crossing Profile
- Catheter Shaft OD, ID, Working Length
- Guard Tube Length
- Catheter Trackability, Pushability, Kinkability (Functional Test)
- Shaft Pull Test
- Leakage
- Catheter Torque Strength
- Proximal Section Pull Test
- Optical Functionality Test
- Fatigue Test
- Catheter Optical Durability
- Evaluation of Hydrophilic Coating
## STERILIZATION/SHELF LIFE/PACKAGING
The Auryon Atherectomy System catheters are sterilized via ethylene oxide (EO). A series of tests, performed by Eximo Medical and independent test houses, have been conducted to assess the suitability of the sterile packaging to protect the Auryon Atherectomy Systems and ensure sterility within its stated shelf life at point of use. These tests confirm the packaging integrity, sterility, and distribution cycle. Testing demonstrated that the packaging is robust enough to withstand extreme distribution conditions at extreme environmental conditions while maintaining packaging integrity and sterility. This submission does not impact the product's sterilization, shelf-life or packaging.
## BIOCOMPATIBILITY
The Auryon Atherectomy System Catheters are a sterile single-use disposable instrument. The Auryon Atherectomy System Catheters have met the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process. Specifically, the following tests were performed with acceptable results; cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility. This submission does not impact the product's biocompatibility.
## CONCLUSION
Assessment of the similarities and differences of the proposed Auryon Atherectomy System and the predicate device concludes that the devices are substantially equivalent to one another; specifically:
- The proposed and predicate device have the same Pro-Code, Regulation Number, Regulation Name, and Regulatory Class;
- The proposed and predicate devices incorporate the identical operating principle, mechanism of action, and are intended for the same patient populations; and,
- With the exception of the newly added catheter size, the proposed and predicate employ an identical overall design, materials of manufacture, performance testing, sizes, and configurations.
The sum of these evaluations and determinations lead Eximo Medical Ltd. to conclude that substantial equivalence has been demonstrated, and that the existing data and additional testing have confirmed that there are no new questions of safety or effectiveness.
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