FDA product code HBO: Clip, Scalp
HBO is the FDA product code for clip, scalp. It is a Class II device, regulated under 21 CFR 882.4150 and reviewed by the Neurology panel. FDA has cleared 11 510(k) submissions under HBO, 1 in the last five years, from 10 different applicants. The average 510(k) review took 86 days (median 77); 235 days on average over the last three years. FDA has posted 3 recalls for HBO devices.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Scalp |
| Device class | Class II |
| Regulation | 21 CFR 882.4150 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 235 |
Compare with all 510(k) review times · Search every HBO clearance
Top HBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 2 | 1991-02-21 |
| Beijing Honghugaoxiang Science and Technology Development CO | 1 | 2026-07-21 |
| Medtronic Neurosurgery | 1 | 2005-02-07 |
| Rudolf Storz GmbH | 1 | 2004-01-07 |
| Aesculap, Inc. | 1 | 2001-07-31 |
5 more applicants have HBO clearances. See the full list in Caduvo.
Most recent HBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253814 | Beijing Honghugaoxiang Science and Technology Development CO | Raney Clips Kit | 2026-07-21 | 235 |
| K050044 | Medtronic Neurosurgery | MEDTRONIC CLIP GUN KIT | 2005-02-07 | 28 |
| K033660 | Rudolf Storz GmbH | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 | 2004-01-07 | 47 |
| K012219 | Aesculap, Inc. | SCALPFIX CLIP SYSTEM | 2001-07-31 | 15 |
| K944311 | Acra Cut, Inc. | ACRA-CUT | 1994-11-18 | 77 |
Recalls for HBO devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-06-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code HBO?
HBO is the FDA product code for clip, scalp. It is a Class II device, regulated under 21 CFR 882.4150 and reviewed by the Neurology panel.
What device class is HBO?
Class II, regulation 21 CFR 882.4150. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBO?
Across 11 cleared submissions the average was 86 days from receipt to decision (median 77).
Which companies have the most HBO clearances?
Codman & Shurtleff, Inc. (2); Beijing Honghugaoxiang Science and Technology Development CO (1); Medtronic Neurosurgery (1); Rudolf Storz GmbH (1); Aesculap, Inc. (1).
Have HBO devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code HBO
- Run a recall and safety report across every HBO manufacturer
- Watch product code HBO 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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