FDA product code KBZ: Snare, Tonsil
KBZ is the FDA product code for snare, 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 KBZ. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Snare, 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 |
Compare with all 510(k) review times · Search every KBZ clearance
Top KBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-24 |
Most recent KBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822188 | Kelleher Corp. | TONSIL SNARES | 1982-08-24 | 32 |
Recalls for KBZ devices
openFDA lists no recalls for product code KBZ.
Frequently asked questions
What is FDA product code KBZ?
KBZ is the FDA product code for snare, 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 KBZ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBZ?
Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most KBZ clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBZ
- Run a recall and safety report across every KBZ manufacturer
- Watch product code KBZ 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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