FDA product code JYR: Nipper, Malleus
JYR is the FDA product code for nipper, malleus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under JYR, from 2 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Nipper, Malleus |
| 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 JYR clearance
Top JYR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-24 |
| Xomed, Inc. | 1 | 1979-06-27 |
Most recent JYR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822170 | Kelleher Corp. | INCUS NIPPERS | 1982-08-24 | 32 |
| K791121 | Xomed, Inc. | ALLIGATOR FORECPTS, CUPPED FORCEPS | 1979-06-27 | 12 |
Recalls for JYR devices
openFDA lists no recalls for product code JYR.
Frequently asked questions
What is FDA product code JYR?
JYR is the FDA product code for nipper, malleus. 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 JYR?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYR?
Across 2 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most JYR clearances?
Kelleher Corp. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYR
- Run a recall and safety report across every JYR manufacturer
- Watch product code JYR 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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