510(k) K252694

Target Detachable Coil by Stryker Neurovascular — Product Code HCG

K252694 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "Target Detachable Coil". The FDA issued a decision of Substantially Equivalent on December 11, 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
December 11, 2025
Date Received
August 26, 2025
Clearance Type
Traditional
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