HCG — Device, Neurovascular Embolization Class II
FDA Device Classification
Classification Details
- Product Code
- HCG
- Device Class
- Class II
- Regulation Number
- 882.5950
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K254221 | balt usa | Optima Coil System (OptiOne Coil System) | January 27, 2026 |
| K252694 | stryker neurovascular | Target Detachable Coil | December 11, 2025 |
| K251832 | stryker neurovascular | InZone IST Detachment System; IZDS Connecting Cable | October 17, 2025 |
| K252700 | balt usa | Optima Coil System (Optima Packing Coil System) | September 26, 2025 |
| K242154 | microport neurotech (shanghai) co | Numen Coil Embolization System; NumenFR Detachment System | September 30, 2024 |
| K242582 | balt usa | Optima Coil System (OptiBlock Line Extension) | September 27, 2024 |
| K242243 | stryker neurovscular | Target Detachable Coils | August 29, 2024 |
| K232955 | microport neurotech (shanghai) co | Numen Coil Embolization System; NumenFR Detachment System | January 10, 2024 |
| K233420 | micro therapeutics lnc. d/b/a ev3 neurovascular | Axium Detachable Coil; Axium Prime Detachable Coil | November 7, 2023 |
| K230284 | penumbra | Penumbra LP Coil System | October 25, 2023 |
| K222533 | stryker neurovascular | Target Tetra Detachable Coils | December 14, 2022 |
| K223386 | balt usa | Optima Coil System | December 6, 2022 |
| K220040 | medos international sarl | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Helif | July 14, 2022 |
| K212455 | stryker neurovascular | InZone Detachment System | November 16, 2021 |
| K203625 | microport neurotech (shanghai) co | Numen Coil Embolization System; NumenFR Detachment System | September 1, 2021 |
| K203432 | micro therapeutics, inc. d/b/a ev3 neurovascular | Axium Detachable Coil; Axium Prime Detachable Coil | July 7, 2021 |
| K211344 | medos international sarl | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini | May 28, 2021 |
| K210638 | kaneka medical america | i-ED COIL System | March 26, 2021 |
| K192068 | kaneka pharma america | i-ED COIL | April 25, 2020 |
| K200030 | balt usa | Optima Coil System | February 1, 2020 |