FDA product code JYE: Chisel, Middle-Ear
JYE is the FDA product code for chisel, middle-ear. 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 JYE. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Chisel, Middle-Ear |
| 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 JYE clearance
Top JYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-16 |
Most recent JYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822165 | Kelleher Corp. | ENT CHISELS | 1982-08-16 | 24 |
Recalls for JYE devices
openFDA lists no recalls for product code JYE.
Frequently asked questions
What is FDA product code JYE?
JYE is the FDA product code for chisel, middle-ear. 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 JYE?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYE?
Across 1 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most JYE clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYE
- Run a recall and safety report across every JYE manufacturer
- Watch product code JYE 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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