FDA product code JZA: Rongeur, Mastoid
JZA is the FDA product code for rongeur, mastoid. 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 JZA. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Rongeur, Mastoid |
| 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 JZA clearance
Top JZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-12 |
Most recent JZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822007 | Kelleher Corp. | BONE RONGEUNS ENT & RELATED ITEMS | 1982-08-12 | 35 |
Recalls for JZA devices
openFDA lists no recalls for product code JZA.
Frequently asked questions
What is FDA product code JZA?
JZA is the FDA product code for rongeur, mastoid. 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 JZA?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZA?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most JZA clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZA
- Run a recall and safety report across every JZA manufacturer
- Watch product code JZA 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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