FDA product code JCQ: Prosthesis, Esophagus
JCQ is the FDA product code for prosthesis, esophagus. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under JCQ. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Esophagus |
| Device class | Class II |
| Regulation | 21 CFR 878.3610 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every JCQ clearance
Top JCQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 1 | 1989-12-27 |
Most recent JCQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896390 | Wilson-Cook Medical, Inc. | WILSON-COOK ESOPHAGEAL PROSTHESIS | 1989-12-27 | 51 |
Recalls for JCQ devices
openFDA lists no recalls for product code JCQ.
Frequently asked questions
What is FDA product code JCQ?
JCQ is the FDA product code for prosthesis, esophagus. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the General and Plastic Surgery panel.
What device class is JCQ?
Class II, regulation 21 CFR 878.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code JCQ?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most JCQ clearances?
Wilson-Cook Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JCQ
- Run a recall and safety report across every JCQ manufacturer
- Watch product code JCQ 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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