OBSIDIO™ Conformable Embolic (M0013972101010)

K253376 · Boston Scientific Corporation · KRD · Oct 30, 2025 · Cardiovascular

Device Facts

• Record ID: K253376
• Device Name: OBSIDIO™ Conformable Embolic (M0013972101010)
• Applicant: Boston Scientific Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Oct 30, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. Delivered via microcatheter into peripheral vasculature; conforms to vessel shape to block blood flow. Tantalum provides fluoroscopic visualization. Operates without precipitation or polymerization. Used by clinicians in interventional settings. Output is physical occlusion of target vessels; aids in hemorrhage control and tumor devascularization. Benefits patient by providing targeted vessel occlusion.

Clinical Evidence

Bench testing only; no clinical data presented. Testing supported the addition of MR Conditional status to the IFU and labels.

Technological Characteristics

Implantable peripheral vascular embolization agent. Composition: pre-hydrated gelatin, layered silicate, tantalum powder, water. Form factor: 1 mL syringe. Delivery: microcatheter. Visualization: fluoroscopy (via tantalum). Sterilization: sterile, single-use. Connectivity: none.

Indications for Use

Indicated for patients requiring embolization of hypervascular tumors or 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)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 30, 2025

Boston Scientific Corporation
Liz Johnston
Regulatory Affairs Specialist
One Scimed Place
Maple Grove, Minnesota 55311

Re: K253376
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: September 30, 2025
Received: September 30, 2025

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"

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K253376 - Liz Johnston
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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 ([e-mail]) or phone [phone] or 301-796-7100).

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K253376 - Liz Johnston
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Sincerely,

FINN E.
DONALDSON - S

Digitally signed by FINN
E. DONALDSON -S
Date: 2025.10.30
11:04:25 -04'00'

Finn Donaldson
Team Lead
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)
Page 1 of 1
PSC Publishing Services [phone]
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) K253376 | |
| Device Name OBSIDIOTM Conformable Embolic | |
| Indications for Use (Describe) The OBSIDIOTM 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 [e-mail] | |
| "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) Summary
OBSIDIO™ Conformable Embolic
K253376
Page 1 of 2

# 510(k) Summary
510(K) Summary Complying with 21 CFR 807.92

# I. SUBMITTER INFORMATION

Submitter Name: Boston Scientific Corporation

Submitter Address:
One Scimed Place
Maple Grove, MN 55311-1566
USA

Telephone: [phone]
e-mail: [e-mail]
Contact person name: Liz Johnston
Date Prepared: September 30, 2025

# II. DEVICE INFORMATION

OBSIDIO™ Conformable Embolic, UPN M0013972101010

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

Name of Predicate Device
OBSIDIO™ Conformable Embolic (K242507, Cleared October 3, 2024)

# 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.

# Intended Use / 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

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K253376
510(k) Summary
OBSIDIO™ Conformable Embolic
Page 2 of 2

# 1. VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject and predicate OBSIDIO™ Conformable Embolic have the same technical 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.

# 2. VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Non-clinical testing was used to support the addition of MR Conditional in the subject OBSIDIO™ Conformable Embolic IFU and labels. 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.

# 3. 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).