FDA product code HCH: Clip, Aneurysm
HCH is the FDA product code for clip, aneurysm. It is a Class II device, regulated under 21 CFR 882.5200 and reviewed by the Neurology panel. FDA has cleared 36 510(k) submissions under HCH, 1 in the last five years, from 18 different applicants. The average 510(k) review took 187 days (median 110). FDA has posted 4 recalls for HCH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Aneurysm |
| Device class | Class II |
| Regulation | 21 CFR 882.5200 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HCH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 386 |
| 2022 | 1 | 316 |
Compare with all 510(k) review times · Search every HCH clearance
Top HCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesculap, Inc. | 10 | 2014-01-24 |
| Codman & Shurtleff, Inc. | 4 | 2009-09-08 |
| Mizuho America, Inc. | 3 | 2022-03-02 |
| Peter Lazic GmbH | 2 | 2019-04-12 |
| V. Mueller Neuro/Spine | 2 | 2000-01-06 |
13 more applicants have HCH clearances. See the full list in Caduvo.
Most recent HCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211183 | Mizuho America, Inc. | Sugita AVM Microclips | 2022-03-02 | 316 |
| K180757 | Peter Lazic GmbH | D-Clip; D-Clip Applier | 2019-04-12 | 386 |
| K131500 | Aesculap, Inc. | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | 2014-01-24 | 245 |
| K091921 | Codman & Shurtleff, Inc. | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP | 2009-09-08 | 70 |
| K081640 | Gimmi GmbH | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | 2009-05-06 | 329 |
Recalls for HCH devices
4 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-07-14.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code HCH?
HCH is the FDA product code for clip, aneurysm. It is a Class II device, regulated under 21 CFR 882.5200 and reviewed by the Neurology panel.
What device class is HCH?
Class II, regulation 21 CFR 882.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCH?
Across 36 cleared submissions the average was 187 days from receipt to decision (median 110).
Which companies have the most HCH clearances?
Aesculap, Inc. (10); Codman & Shurtleff, Inc. (4); Mizuho America, Inc. (3); Peter Lazic GmbH (2); V. Mueller Neuro/Spine (2).
Have HCH devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code HCH
- Run a recall and safety report across every HCH manufacturer
- Watch product code HCH 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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