510(k) K242243
K242243 is an FDA 510(k) premarket notification submitted by Stryker Neurovscular for the device "Target Detachable Coils". The FDA issued a decision of Substantially Equivalent on August 29, 2024. 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
- August 29, 2024
- Date Received
- July 31, 2024
- 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