FDA product code JYL: Hook, Microsurgical Ear
JYL is the FDA product code for hook, 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 5 510(k) submissions under JYL, from 3 different applicants. The average 510(k) review took 39 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Hook, 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 JYL clearance
Top JYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 2 | 1982-08-25 |
| Edward Weck, Inc. | 2 | 1978-02-27 |
| Imm Enterprises , Ltd. | 1 | 1984-03-06 |
Most recent JYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834188 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 10/43 | 1984-03-06 | 106 |
| K822195 | Kelleher Corp. | MIRCOSURGICAL INSTRUMENTS | 1982-08-25 | 33 |
| K822166 | Kelleher Corp. | MICROSURGICAL EAR HOOK | 1982-08-20 | 28 |
| K780287 | Edward Weck, Inc. | DAY HEAR HOOK | 1978-02-27 | 6 |
| K772390 | Edward Weck, Inc. | DAY EAR HOOK | 1978-01-17 | 21 |
Recalls for JYL devices
openFDA lists no recalls for product code JYL.
Frequently asked questions
What is FDA product code JYL?
JYL is the FDA product code for hook, 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 JYL?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYL?
Across 5 cleared submissions the average was 39 days from receipt to decision (median 28).
Which companies have the most JYL clearances?
Kelleher Corp. (2); Edward Weck, Inc. (2); Imm Enterprises , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYL
- Run a recall and safety report across every JYL manufacturer
- Watch product code JYL 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times