Target Xtra Detachable Coil— 510(k) K261772

Name: FDA 510(k) clearance K261772
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Substantially Equivalent

Stryker Neurovscular

FDA 510(k) clearance K261772 for Target Xtra Detachable Coil, Substantially Equivalent on 2026-06-24. Applicant: Stryker Neurovscular. Device class: 2.

Clearance details

Applicant: Stryker Neurovscular
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2026-05-29
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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K251832 — InZone IST Detachment System; IZDS Connecting Cable2025-10-17

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K242243 — Target Detachable Coils2024-08-29

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.