FDA product code JCW: Prosthesis, Penis, Inflatable
JCW is the FDA product code for prosthesis, penis, inflatable. It is a Class III device, regulated under 21 CFR 876.3350 and reviewed by the Gastroenterology and Urology panel. Devices under JCW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 19 recalls for JCW devices, 7 initiated in the last five years.
Definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Penis, Inflatable |
| Device class | Class III |
| Regulation | 21 CFR 876.3350 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for JCW devices
19 product recalls in 8 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2025-09-11.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code JCW?
JCW is the FDA product code for prosthesis, penis, inflatable. It is a Class III device, regulated under 21 CFR 876.3350 and reviewed by the Gastroenterology and Urology panel.
What device class is JCW?
Class III, regulation 21 CFR 876.3350. Typical premarket route: PMA.
Have JCW devices been recalled?
Yes: 19 product recalls across 8 recall events; the most recent began 2025-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JCW
- Run a recall and safety report across every JCW manufacturer
- Watch product code JCW 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times