FDA product code JZE: Spoon, Ear
JZE is the FDA product code for spoon, 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 JZE. The average 510(k) review took 85 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | Spoon, 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 JZE clearance
Top JZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 1 | 1989-01-18 |
Most recent JZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884483 | Orthopedic Systems, Inc. | CRUCIOMETER | 1989-01-18 | 85 |
Recalls for JZE devices
openFDA lists no recalls for product code JZE.
Frequently asked questions
What is FDA product code JZE?
JZE is the FDA product code for spoon, 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 JZE?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZE?
Across 1 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most JZE clearances?
Orthopedic Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZE
- Run a recall and safety report across every JZE manufacturer
- Watch product code JZE 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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