FDA product code HBN: Chair, Neurosurgical
HBN is the FDA product code for chair, neurosurgical. It is a Class I device, regulated under 21 CFR 882.4125 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under HBN, from 3 different applicants. The average 510(k) review took 70 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Chair, Neurosurgical |
| Device class | Class I |
| Regulation | 21 CFR 882.4125 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HBN clearance
Top HBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgi-Quip Inc.U | 2 | 1982-09-02 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 1990-09-04 |
| Kelleher Corp. | 1 | 1982-07-30 |
Most recent HBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900472 | Skytron, Div. the Kmw Group, Inc. | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | 1990-09-04 | 216 |
| K822426 | Surgi-Quip Inc.U | MCINTYRE MICROSCOPE STAND | 1982-09-02 | 21 |
| K822428 | Surgi-Quip Inc.U | SURGI-QUIP MICROSCOPE STAND | 1982-09-02 | 21 |
| K822012 | Kelleher Corp. | BINOCULAR OPERATING MICROSCOPES & | 1982-07-30 | 22 |
Recalls for HBN devices
openFDA lists no recalls for product code HBN.
Frequently asked questions
What is FDA product code HBN?
HBN is the FDA product code for chair, neurosurgical. It is a Class I device, regulated under 21 CFR 882.4125 and reviewed by the Neurology panel.
What device class is HBN?
Class I, regulation 21 CFR 882.4125. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HBN?
Across 4 cleared submissions the average was 70 days from receipt to decision (median 22).
Which companies have the most HBN clearances?
Surgi-Quip Inc.U (2); Skytron, Div. the Kmw Group, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HBN
- Run a recall and safety report across every HBN manufacturer
- Watch product code HBN 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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