FDA product code JYG: Curette, Ear
JYG is the FDA product code for curette, 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 7 510(k) submissions under JYG, from 5 different applicants. The average 510(k) review took 51 days (median 35). FDA has posted 1 recall for JYG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Curette, 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 JYG clearance
Top JYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 2 | 1984-07-06 |
| Kelleher Corp. | 2 | 1982-08-30 |
| Ear Tech, Inc. | 1 | 1993-07-21 |
| Bionix Corp. | 1 | 1985-06-11 |
| Premier Dental Products Co. | 1 | 1984-05-29 |
Most recent JYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932609 | Ear Tech, Inc. | EAR CURETTE | 1993-07-21 | 54 |
| K852039 | Bionix Corp. | FLEX-LOOP FLEXIBLE EAR CORETTE | 1985-06-11 | 33 |
| K841354 | Treace Medical, Inc. | CURETTE | 1984-07-06 | 95 |
| K841001 | Premier Dental Products Co. | EAR CURETTE, VARIOUS | 1984-05-29 | 81 |
| K823916 | Treace Medical, Inc. | WAX CURETTE TIP | 1983-01-21 | 24 |
Recalls for JYG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code JYG?
JYG is the FDA product code for curette, 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 JYG?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYG?
Across 7 cleared submissions the average was 51 days from receipt to decision (median 35).
Which companies have the most JYG clearances?
Treace Medical, Inc. (2); Kelleher Corp. (2); Ear Tech, Inc. (1); Bionix Corp. (1); Premier Dental Products Co. (1).
Have JYG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JYG
- Run a recall and safety report across every JYG manufacturer
- Watch product code JYG 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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