510(k) K261772

Target Xtra Detachable Coil by Stryker Neurovscular — Product Code HCG

K261772 is an FDA 510(k) premarket notification submitted by Stryker Neurovscular for the device "Target Xtra Detachable Coil". The FDA issued a decision of Substantially Equivalent on June 24, 2026. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Stryker Neurovscular has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2026
Date Received
May 29, 2026
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