HCG — Device, Neurovascular Embolization Class II
FDA product code HCG covers "Device, Neurovascular Embolization", a Class II medical device regulated under 21 CFR 882.5950. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261772 | stryker neurovscular | Target Xtra Detachable Coil | June 24, 2026 |
| K260351 | microport neurotech (shanghai) co | Numen Helia Coil Embolization System; NumenFR Detachment System | May 20, 2026 |
| 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 |