OBSIDIO Conformable Embolic
Device Facts
| Record ID | K261488 |
|---|---|
| Device Name | OBSIDIO Conformable Embolic |
| Applicant | Boston Scientific Corporation |
| Product Code | KRD · Cardiovascular |
| Decision Date | Jul 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K261488 · Jul 24, 2026 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | OCCLUDE Registry (NCT06170619) | The OCCLUDE Registry provided clinical evidence of technical success and safety (freedom from MAE) in 125 patients to support the labeling update for microcatheter compatibility. | Registry; Clinical outcomes; Post-approval |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| OCCLUDE Registry (NCT06170619); Prospective, post-approval, open-label, single arm, multi-center registry; Follow-up/Duration: 30 days | Patients undergoing embolization with Obsidio™ Conformable Embolic; Sample Size: 125; Number of Sites: Multi-center | Not applicable for this study | Technical success; Freedom from MAE through 30 days |
Indications for Use
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of: - Hypervascular tumors - Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature
Device Story
OBSIDIO Conformable Embolic is a premixed, sterile, single-use embolic agent; composed of pre-hydrated gelatin, layered silicate, and tantalum powder for fluoroscopic visualization. Delivered via microcatheter into peripheral blood vessels; blocks blood flow through physical occlusion rather than precipitation or polymerization. Material conforms to vessel shape. Used by physicians in clinical settings for hypervascular tumor embolization and hemorrhage control. Output is vessel occlusion; visualized via fluoroscopy. Benefits include targeted flow reduction. Subject device updates include compatibility with 0.021-inch inner diameter microcatheters, supported by injection force bench testing, acute porcine animal studies, and clinical data from the OCCLUDE Registry.
Clinical Evidence
Supported by the OCCLUDE Registry (NCT06170619), a prospective, open-label, single-arm, multi-center US study (N=125). Patients underwent embolization with Obsidio™ Conformable Embolic using microcatheters <0.024 inches. Primary effectiveness endpoint (technical success) was 100% (125/125). Primary safety endpoint (freedom from Major Adverse Events through 30 days) was 97.4%. Data confirms safety and effectiveness for the updated catheter compatibility.
Technological Characteristics
Implantable peripheral vascular embolization device. Materials: pre-hydrated gelatin, layered silicate, tantalum, water. Form factor: 1 mL syringe. Delivery: microcatheter-based. Sterilization: sterile, single-use. Connectivity: N/A. Principle: mechanical occlusion via conformable material.
Indications for Use
Indicated for embolization of hypervascular tumors and peripheral blood vessels to occlude flow for hemorrhage control.
Regulatory Classification
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Predicate Devices
- OBSIDIO™ Conformable Embolic (K242507)
Reference Devices
- OBSIDIO™ Conformable Embolic (K253376)
Submission Summary (Full Text)
{0}
**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 24, 2026
Boston Scientific Corporation
Liz Johnston
Senior Specialist, Regulatory Affairs
One Scimed Pl.
Maple Grove, Minnesota 55311
Re: K261488
Trade/Device Name: OBSIDIO Conformable Embolic
Regulation Number: 21 CFR 870.3300
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Product Code: KRD
Dated: May 26, 2026
Received: May 27, 2026
Dear Liz Johnston:
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"
{1}
K261488 - Liz Johnston
Page 2
(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).
{2}
K261488 - Liz Johnston
Page 3
Sincerely, FINN E. DONALDSON -S Digitally signed by FINN E. DONALDSON -S Date: 2026.07.24 12:19:19 -04'00'
Finn Donaldson
Acting 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
{3}
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)
K261488
Device Name
OBSIDIO™ Conformable Embolic
Indications for Use (Describe)
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors
- Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature
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."*
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
510(k) Summary
OBSIDIO™ Conformable Embolic
K261488
Page 1 of 2
# 510(k) Summary
510(K) Summary Complying with 21 CFR 807.92
# I. SUBMITTER INFORMATION
Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311-1566
USA
Telephone: (508) 683-4000
Contact person name: Liz Johnston
email: Liz.Johnston@bsci.com
Date Prepared: May 5, 2026
# II. DEVICE
OBSIDIO™ Conformable Embolic
Table 1: Device Information
| Common or Usual name | Regulatory Number | Regulatory Name | Product Code | Product Code Name | Regulatory Class |
| --- | --- | --- | --- | --- | --- |
| Vascular embolization device | 21 CFR Part 870.3300 | Vascular Embolization Device | KRD | Device, Vascular, For Promoting Embolization | II |
# III. PREDICATE DEVICE IDENTIFICATION
Predicate Device: OBSIDIO™ Conformable Embolic K242507
Reference Device: OBSIDIO™ Conformable Embolic K253376
# IV. DEVICE DESCRIPTION
The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). OBSIDIO Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. OBSIDIO Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.
# V. INDICATIONS FOR USE
Predicate and subject device intended use / indications for use are the same.
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors,
- Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature.
{5}
510(k) Summary
OBSIDIO™ Conformable Embolic
K261488
Page 2 of 2
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject and predicate OBSIDIO™ Conformable Embolic have the same technological characteristics. The device is an implantable peripheral vascular embolization device composed of pre-hydrated gelatin, layered silicate, tantalum, and water. The material is contained in a 1 mL syringe and supplied as a sterile, single use product within one sterile barrier peelable pouch per shelf carton. Subject and predicate device have the same principle of operation, the same delivery method (catheter delivery) with the updates of the minimum delivery catheter size based on added performance testing (see below), biocompatibility and shelf life. No changes to the device design or materials are part of the updates in this submission.
## VII. PERFORMANCE DATA
The testing used to support this change: 1.) Injection force performance testing, 2.) Acute animal study, 3.) Clinical data from the OCCLUDE Registry.
Bench testing evaluated catheter compatibility and delivery performance by measuring injection force required to deliver the device through a 0.021-inch inner diameter microcatheter under simulated worst-case conditions.
Animal testing in an acute porcine model confirmed catheter compatibility, delivery performance measured by injection force, occlusion performance, and device responsiveness when delivered through a 0.021-inch catheter.
The OCCLUDE Registry (NCT06170619) is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. A total of 125 patients were enrolled and treated. Following the index procedure, patients were followed for 30 days, with specific study visits including Hospital Discharge, a Day 7 phone call or office visit, and a 1-month follow-up phone call or office visit. The primary effectiveness endpoint, technical success was achieved in 100% (125/125) of treated subjects overall. The primary safety endpoint—freedom from MAE through 30 days—was achieved in 97.4% of evaluable subjects. The Registry included use of microcatheters with inner diameters <0.024 inches, providing clinical experience relevant to the labeling change.
Non-clinical (bench, animal) and clinical data were used to support the update of 0.021-inch catheter in the subject OBSIDIO™ Conformable Embolic IFU. The test results provide reasonable assurance that the proposed device has been designed and tested to ensure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.
## VIII. CONCLUSION
Based on the intended use, technological characteristics, and the safety and performance data provided, the OBSIDIO™ Conformable Embolic is considered appropriate for the intended use and substantially equivalent to the predicate device (K242507).
