FDA product code JYY: Rasp, Ear
JYY is the FDA product code for rasp, 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 JYY. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Rasp, 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 JYY clearance
Top JYY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-25 |
Most recent JYY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822253 | Kelleher Corp. | RASPS | 1982-08-25 | 27 |
Recalls for JYY devices
openFDA lists no recalls for product code JYY.
Frequently asked questions
What is FDA product code JYY?
JYY is the FDA product code for rasp, 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 JYY?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYY?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most JYY clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYY
- Run a recall and safety report across every JYY manufacturer
- Watch product code JYY 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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