Target Xtra Detachable Coil— 510(k) K261772
Substantially EquivalentStryker Neurovscular
FDA 510(k) clearance K261772 for Target Xtra Detachable Coil, Substantially Equivalent on 2026-06-24. Applicant: Stryker Neurovscular. Device class: 2.
Summary
The Target Xtra Detachable Coil is filed under HCG, neurovascular embolization devices. The applicant is listed as Stryker Neurovscular (spelled that way in the record), and the record gives no coil sizes.
Class II, 21 CFR 882.5950. Neurology is both the classification panel and the review panel, and it came in as a Special 510(k).
The applicant filed from Fremont, California. The decision came 26 calendar days after FDA received it (May 29 to June 24, 2026).
Clearance details
- Applicant
- Stryker Neurovscular
- Product code
- Product code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fremont, CA, US
Recent devices under product code HCG
view allMore clearances from Stryker Neurovscular
view allAdverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.