HCG
- Product code
- HCG
- Device name
- Device, Neurovascular Embolization
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5950
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 13
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 187 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262419 | 2026-08-14 | Cerenovus, Inc. | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MI… | |
| K261772 | 2026-06-24 | Stryker Neurovscular | Target Xtra Detachable Coil | |
| K260351 | 2026-05-20 | MicroPort NeuroTech (Shanghai) Co., Lt… | Numen Helia Coil Embolization System; NumenFR Deta… | FDA |
| K254221 | 2026-01-27 | Balt USA, LLC | Optima Coil System (OptiOne Coil System) | |
| K252694 | 2025-12-11 | Stryker Neurovascular | Target Detachable Coil | |
| K251832 | 2025-10-17 | Stryker Neurovascular | InZone IST Detachment System; IZDS Connecting Cable | |
| K252700 | 2025-09-26 | Balt USA, LLC | Optima Coil System (Optima Packing Coil System) | |
| K242154 | 2024-09-30 | MicroPort NeuroTech (Shanghai) Co., Lt… | Numen Coil Embolization System; NumenFR Detachment… | |
| K242582 | 2024-09-27 | Balt USA, LLC | Optima Coil System (OptiBlock Line Extension) | |
| K242243 | 2024-08-29 | Stryker Neurovscular | Target Detachable Coils | |
| K232955 | 2024-01-10 | MicroPort NeuroTech (Shanghai) Co., Lt… | Numen Coil Embolization System; NumenFR Detachment S… | FDA |
| K233420 | 2023-11-07 | Micro Therapeutics Lnc. D/B/A Ev3 Neur… | Axium Detachable Coil; Axium Prime Detachable Coil | FDA |
| K230284 | 2023-10-25 | Penumbra, Inc. | Penumbra LP Coil System |
Official FDA classification page: HCG
Classification and pathway per current FDA publications. Data from openFDA (CC0).