FDA product code JYT: Pick, Microsurgical Ear
JYT is the FDA product code for pick, microsurgical 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 2 510(k) submissions under JYT, from 2 different applicants. The average 510(k) review took 58 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Pick, Microsurgical 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 JYT clearance
Top JYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 1 | 1984-07-03 |
| Kelleher Corp. | 1 | 1982-08-16 |
Most recent JYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841355 | Treace Medical, Inc. | RIGHT ANGLED PICK | 1984-07-03 | 92 |
| K822176 | Kelleher Corp. | MICROSURGICAL EAR PICKS | 1982-08-16 | 24 |
Recalls for JYT devices
openFDA lists no recalls for product code JYT.
Frequently asked questions
What is FDA product code JYT?
JYT is the FDA product code for pick, microsurgical 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 JYT?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYT?
Across 2 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most JYT clearances?
Treace Medical, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYT
- Run a recall and safety report across every JYT manufacturer
- Watch product code JYT 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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