FDA product code JYC: Cannula, Ear
JYC is the FDA product code for cannula, ear. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under JYC, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Ear |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JYC clearance
Top JYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1989-05-01 |
| Edward Weck, Inc. | 1 | 1978-02-02 |
Most recent JYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891269 | Syva Co. | MICROTRAK EIA AUTOWASHER | 1989-05-01 | 53 |
| K780153 | Edward Weck, Inc. | HOUSE SUCTION IRRIGATOR | 1978-02-02 | 3 |
Recalls for JYC devices
openFDA lists no recalls for product code JYC.
Frequently asked questions
What is FDA product code JYC?
JYC is the FDA product code for cannula, ear. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is JYC?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYC?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most JYC clearances?
Syva Co. (1); Edward Weck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYC
- Run a recall and safety report across every JYC manufacturer
- Watch product code JYC 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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