K251832
- 510(k) number
- K251832
- Device name
- InZone IST Detachment System; IZDS Connecting Cable
- Applicant
- Stryker Neurovascular CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2025-10-17
- Date received
- 2025-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251832.pdf
Official FDA record: K251832
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.