FDA product code JYQ: Loop, Wire
JYQ is the FDA product code for loop, wire. 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 JYQ, from 2 different applicants. The average 510(k) review took 7 days (median 7).
Classification
| Field | Value |
|---|---|
| Device name | Loop, Wire |
| 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 JYQ clearance
Top JYQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 1 | 1989-01-27 |
| Treace Medical, Inc. | 1 | 1987-03-03 |
Most recent JYQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890221 | Kinetic Medical Products | MICROSURGICAL WIRE LOOP | 1989-01-27 | 9 |
| K870761 | Treace Medical, Inc. | EAR LOOP | 1987-03-03 | 5 |
Recalls for JYQ devices
openFDA lists no recalls for product code JYQ.
Frequently asked questions
What is FDA product code JYQ?
JYQ is the FDA product code for loop, wire. 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 JYQ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYQ?
Across 2 cleared submissions the average was 7 days from receipt to decision (median 7).
Which companies have the most JYQ clearances?
Kinetic Medical Products (1); Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYQ
- Run a recall and safety report across every JYQ manufacturer
- Watch product code JYQ 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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