FDA product code HCG: Device, Neurovascular Embolization
HCG is the FDA product code for device, neurovascular embolization. It is a Class II device, regulated under 21 CFR 882.5950 and reviewed by the Neurology panel. FDA has cleared 187 510(k) submissions under HCG, 16 in the last five years, from 39 different applicants. The average 510(k) review took 102 days (median 74); 65 days on average over the last three years. FDA has posted 68 recalls for HCG devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Neurovascular Embolization |
| Device class | Class II |
| Regulation | 21 CFR 882.5950 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HCG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 99 |
| 2018 | 4 | 189 |
| 2019 | 1 | 30 |
| 2020 | 2 | 146 |
| 2021 | 5 | 128 |
| 2022 | 3 | 111 |
| 2023 | 2 | 146 |
| 2024 | 4 | 59 |
| 2025 | 3 | 87 |
| 2026 | 4 | 48 |
Compare with all 510(k) review times · Search every HCG clearance
Top HCG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| MicroVention, Inc. | 32 | 2017-03-29 |
| Cordis Neurovascular, Inc. | 12 | 2008-09-12 |
| Stryker Neurovascular | 11 | 2025-12-11 |
| Boston Scientific Corp | 11 | 2011-02-16 |
| Micrus Endovascular Corporation | 11 | 2009-01-02 |
34 more applicants have HCG clearances. See the full list in Caduvo.
Most recent HCG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262419 | Cerenovus, Inc. | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | 2026-08-14 | 30 |
| K261772 | Stryker Neurovscular | Target Xtra Detachable Coil | 2026-06-24 | 26 |
| K260351 | MicroPort NeuroTech (Shanghai) Co., Ltd. | Numen Helia Coil Embolization System; NumenFR Detachment System | 2026-05-20 | 106 |
| K254221 | Balt USA, LLC | Optima Coil System (OptiOne Coil System) | 2026-01-27 | 29 |
| K252694 | Stryker Neurovascular | Target Detachable Coil | 2025-12-11 | 107 |
Recalls for HCG devices
68 product recalls in 20 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2026-04-06.
| Year | Recalls |
|---|---|
| 2019 | 17 |
| 2022 | 4 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HCG?
HCG is the FDA product code for device, neurovascular embolization. It is a Class II device, regulated under 21 CFR 882.5950 and reviewed by the Neurology panel.
What device class is HCG?
Class II, regulation 21 CFR 882.5950. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCG?
Across 187 cleared submissions the average was 102 days from receipt to decision (median 74).
Which companies have the most HCG clearances?
MicroVention, Inc. (32); Cordis Neurovascular, Inc. (12); Stryker Neurovascular (11); Boston Scientific Corp (11); Micrus Endovascular Corporation (11).
Have HCG devices been recalled?
Yes: 68 product recalls across 20 recall events; the most recent began 2026-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HCG
- Run a recall and safety report across every HCG manufacturer
- Watch product code HCG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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