510(k) K251832

InZone IST Detachment System; IZDS Connecting Cable by Stryker Neurovascular — Product Code HCG

K251832 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "InZone IST Detachment System; IZDS Connecting Cable". The FDA issued a decision of Substantially Equivalent on October 17, 2025. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Stryker Neurovascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2025
Date Received
June 16, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type