FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Target Detachable Coils
K Number: K242243
·
Decision Aug 29, 2024
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
1
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Target Detachable Coils
- K Number
- K242243
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Neurovscular
- Date Received
- July 31, 2024
- Decision Date
- August 29, 2024
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HCG), ordered by most recent decision date.
Numen Helia Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (OptiOne Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Target Detachable Coil
FDA 510(k)
FDA Class 2
·Neurology
InZone IST Detachment System; IZDS Connecting Cable
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (Optima Packing Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology