FDA product code JYD: Chisel, Mastoid
JYD is the FDA product code for chisel, mastoid. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under JYD. The average 510(k) review took 62 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Chisel, Mastoid |
| 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 JYD clearance
Top JYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GE Medical Systems | 1 | 1993-11-08 |
Most recent JYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934367 | GE Medical Systems | PC-MINI | 1993-11-08 | 62 |
Recalls for JYD devices
openFDA lists no recalls for product code JYD.
Frequently asked questions
What is FDA product code JYD?
JYD is the FDA product code for chisel, mastoid. 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 JYD?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYD?
Across 1 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most JYD clearances?
GE Medical Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYD
- Run a recall and safety report across every JYD manufacturer
- Watch product code JYD 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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