FDA product code KBO: Guillotine, Tonsil
KBO is the FDA product code for guillotine, tonsil. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KBO. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Guillotine, Tonsil |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Top KBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-30 |
Most recent KBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822274 | Kelleher Corp. | MYLE'S GUILLOTINE | 1982-08-30 | 32 |
Recalls for KBO devices
openFDA lists no recalls for product code KBO.
Frequently asked questions
What is FDA product code KBO?
KBO is the FDA product code for guillotine, tonsil. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KBO?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBO?
Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most KBO clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBO
- Run a recall and safety report across every KBO manufacturer
- Watch product code KBO 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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