Target Detachable Coil

K252694 · Stryker Neurovascular · HCG · Dec 11, 2025 · Neurology

Device Facts

• Record ID: K252694
• Device Name: Target Detachable Coil
• Applicant: Stryker Neurovascular
• Product Code: HCG · Neurology
• Decision Date: Dec 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: • Intracranial aneurysms • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae • Arterial and venous embolizations in the peripheral vasculature

Device Story

Target Detachable Coils are platinum-tungsten alloy coils attached to stainless steel delivery wires; used for endovascular obstruction/occlusion of blood flow in neurovascular and peripheral vascular abnormalities. Operated by physicians in clinical settings; coils are delivered via microcatheters to target sites. Detachment is achieved using the InZone Detachment System (sold separately). The device is compatible with both transfemoral and transradial access routes. By occluding blood flow, the coils facilitate embolization of aneurysms and malformations, providing therapeutic benefit by reducing or eliminating flow into the target vascular abnormality.

Clinical Evidence

Bench testing only. Performance evaluated via tracking and deployment testing in clinically representative access models comparing radial vs. femoral access. Metrics included microcatheter friction, ease of deployment/retraction, and track force (advance/pullback). Results showed no noticeable or statistical differences between access routes.

Technological Characteristics

Materials: Platinum-tungsten alloy coil, stainless steel delivery wire. Form factor: Secondary coil diameters 1-24 mm, lengths 1-50 cm. Shapes: Helical, 360, 3D, Tetrahedral. Sterilization: Ethylene Oxide (EtO). Connectivity: Compatible with InZone Detachment System. No software/algorithm components.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in peripheral vasculature.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

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 § 882.1(e).

Predicate Devices

• Target Detachable Coil (K242243)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 11, 2025

Stryker Neurovascular
Genae Tripp
Staff Regulatory Affairs Specialist
47900 Bayside Parkway
Fremont, California 94538-2588

Re: K252694
Trade/Device Name: Target Detachable Coils
Regulation Number: 21 CFR 882.5950
Regulation Name: Neurovascular Embolization Device
Regulatory Class: Class II
Product Code: HCG, KRD
Dated: August 26, 2025
Received: August 26, 2025

Dear Genae Tripp:

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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K252694 - Genae Tripp
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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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K252694 - Genae Tripp
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Sincerely,

SARA S. THOMPSON -S

Sara S. Thompson, D.V.M.
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine 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) K252694 | |
| Device Name Target Detachable Coils | |
| Indications for Use (Describe) Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: • Intracranial aneurysms • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae • Arterial and venous embolizations 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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Stryker Neurovascular
510(k) Summary, K252694
Target Detachable Coils

Date Prepared: December 5, 2025

Submitter: Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
Facility Registration #300853977

Contact: Genae Tripp
Staff Regulatory Affairs Specialist
Tel [phone]
E-mail: [e-mail]

Device Trade Name: Target Detachable Coils

Classification Name: Target Detachable Coils are vascular and neurovascular embolization devices under 21 CFR 870.3300 (KRD) and 21 CFR 882.5950 (HCG), respectively, and are Class II devices (special controls).

The special control for the devices is FDA’s guidance document, Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (issued 29 Dec 2004).

Legally Marketed Predicate Device: K242243 (Cleared 29 Aug 2024)

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Stryker Neurovascular

510(k) Summary, K252694

Target Detachable Coils

# DEVICE DESCRIPTION

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:

| Target 360 Nano | Target Helical Nano | Target XL 360 Soft |
| --- | --- | --- |
| Target 360 Ultra | Target Helical Ultra | Target XL 360 Standard |
| Target 360 Soft | Target 3D | Target XL Helical |
| Target 360 Standard | Target XXL 360 | Target Tetra |

Please note that all Target Detachable Coils referenced in this submission are considered the Subject Device.

Target Detachable Coils are stretch resistant, electrolytically detachable coils consisting of a platinum-tungsten alloy coil attached to a stainless steel delivery wire.

Target Detachable Coils are specifically designed for use with Stryker Neurovascular’s InZone® Detachment System (sold separately).

Target Detachable Coils are compatible with Stryker Neurovascular 2-tip marker microcatheters; refer to Instructions for Use (IFU) for the compatible microcatheter sizes.

# COMPARISON TO THE PREDICATE DEVICE: TARGET DETACHABLE COILS

This 510(k) requests clearance for the revised Instructions for Use to support the use of Target Detachable Coils via transradial access in addition to the existing use via transfemoral access.

A comparison of the subject device with the predicate device is summarized in Table 1 below.

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Stryker Neurovascular

510(k) Summary, K252694

Target Detachable Coils

Table 1. Substantial Equivalence Comparison

| Characteristic | Predicate Device K242243 | Subject Device |
| --- | --- | --- |
| Manufacturer | Stryker | Same |
| Trade Name | Target Detachable Coil | Same |
| Device Type | Vascular Embolization Device; Neurovascular Embolization Device | Same |
| Classification | 870.3300, Class 2 | Same |
| Regulation (21 CFR) | 882.5950, Class 2 | Same |
| Product Code: | KRD, HCG | Same |
| Intended Use/Indication for Use | Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils are indicated for endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolization’s in the peripheral vasculature | Same |
| How Supplied | Single Use/Sterile | Same |
| Method of Sterilization | Ethylene Oxide (EtO) Gas | Same |
| Coil Material | Platinum/Tungsten alloy | Same |
| Delivery Wire Material | Stainless steel | Same |
| Features | | |
| Secondary Coil Outer Diameter | 1 mm – 24 mm | Same |
| Coil Length | 1 cm – 50 cm | Same |
| Coil Secondary Shape Types | Helical, 360, 3D, Tetrahedral | Same |
| Power Supply Compatibility | InZone® Detachment System | Same |
| Packaging Configuration and Materials | Pouch: Tyvek/Film pouch
Carton: Chipboard carton
Dispenser coil (Hoop):
HDPE tubing and clips | Same |

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Stryker Neurovascular

510(k) Premarket Notification

Target Detachable Coils

# ACCESSORIES

Target Detachable Coils are not packaged with any accessories.

# INTENDED USE / INDICATIONS FOR USE:

Intended Use:

Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Indications for Use:

Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for endovascular embolization of:

- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature

# BIOCOMPATIBILITY

The biocompatibility profile of the products remains unchanged, and previous biocompatibility assessments remain applicable.

# PERFORMANCE TESTING

## Bench Testing

Non-clinical bench testing was performed to assess the tracking and deployment performance of Target Detachable Coils through radial access, and to compare these results with femoral access using clinically representative access models.

| Parameter | Results |
| --- | --- |
| Microcatheter Friction | No noticeable difference between radial access and femoral access |
| Ease of Deployment | No noticeable difference between radial access and femoral access |
| Ease of Retraction | No noticeable difference between radial access and femoral access |
| Any noticeable difference in device behavior | No noticeable difference between radial access and femoral access |
| Track Force Testing – Advance Force | No statistical difference between radial access and femoral access |
| Track Force Testing – Pullback Force | No statistical difference between radial access and femoral access |

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Stryker Neurovascular
510(k) Premarket Notification
Target Detachable Coils

CONCLUSION

Because the proposed changes to the subject device do not alter the intended use or indications for use of the predicate device, nor its fundamental scientific technology, and the risk assessment of these changes raises no new questions regarding safety and effectiveness, Stryker Neurovascular has determined that the proposed change to the subject device is substantially equivalent to the predicate device.

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