FDA product code HCI: Applier, Aneurysm Clip
HCI is the FDA product code for applier, aneurysm clip. It is a Class II device, regulated under 21 CFR 882.4175 and reviewed by the Neurology panel. FDA has cleared 14 510(k) submissions under HCI, 1 in the last five years, from 9 different applicants. The average 510(k) review took 114 days (median 72). FDA has posted 5 recalls for HCI devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Applier, Aneurysm Clip |
| Device class | Class II |
| Regulation | 21 CFR 882.4175 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HCI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 1 | 8 |
| 2021 | 1 | 206 |
| 2022 | 1 | 29 |
Compare with all 510(k) review times · Search every HCI clearance
Top HCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesculap, Inc. | 5 | 2021-12-13 |
| Downs Surgical , Ltd. | 2 | 1988-06-06 |
| Mizuho America, Inc. | 1 | 2022-06-24 |
| Medicon EG | 1 | 2001-08-01 |
| Nmt Medical, Inc. | 1 | 2000-02-08 |
4 more applicants have HCI clearances. See the full list in Caduvo.
Most recent HCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221524 | Mizuho America, Inc. | Sugita AVM Microclip Applier | 2022-06-24 | 29 |
| K211572 | Aesculap, Inc. | Aesculap Slim Clip Applier | 2021-12-13 | 206 |
| K180914 | Aesculap, Inc. | Aesculap Slim Clip Applier | 2018-04-17 | 8 |
| K173271 | Aesculap, Inc. | Aesculap Slim Clip Applier Forceps | 2017-11-10 | 29 |
| K010910 | Medicon EG | MEDICON YASARGIL CLIP APPLYING FORCEPS | 2001-08-01 | 128 |
Recalls for HCI devices
5 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-10-06.
| Year | Recalls |
|---|---|
| 2023 | 3 |
Frequently asked questions
What is FDA product code HCI?
HCI is the FDA product code for applier, aneurysm clip. It is a Class II device, regulated under 21 CFR 882.4175 and reviewed by the Neurology panel.
What device class is HCI?
Class II, regulation 21 CFR 882.4175. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCI?
Across 14 cleared submissions the average was 114 days from receipt to decision (median 72).
Which companies have the most HCI clearances?
Aesculap, Inc. (5); Downs Surgical , Ltd. (2); Mizuho America, Inc. (1); Medicon EG (1); Nmt Medical, Inc. (1).
Have HCI devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2023-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HCI
- Run a recall and safety report across every HCI manufacturer
- Watch product code HCI 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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