FDA product code JYP: Knife, Myringotomy
JYP is the FDA product code for knife, myringotomy. 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 JYP. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Myringotomy |
| 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 JYP clearance
Top JYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-16 |
Most recent JYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822162 | Kelleher Corp. | MYRINGOTOMY KNIFE (VARIOUS TYPES) | 1982-08-16 | 24 |
Recalls for JYP devices
openFDA lists no recalls for product code JYP.
Frequently asked questions
What is FDA product code JYP?
JYP is the FDA product code for knife, myringotomy. 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 JYP?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYP?
Across 1 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most JYP clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYP
- Run a recall and safety report across every JYP manufacturer
- Watch product code JYP 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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