FDA product code FHW: Device, Impotence, Mechanical/Hydraulic
FHW is the FDA product code for device, impotence, mechanical/hydraulic. It is a Class III device, regulated under 21 CFR 876.3350 and reviewed by the Gastroenterology and Urology panel. Devices under FHW reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 20 recalls for FHW devices, 18 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 | Device, Impotence, Mechanical/Hydraulic |
| 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 FHW devices
20 product recalls in 4 recall events; 18 initiated in the last five years and 17 still open. Most recent: 2023-03-01.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 17 |
Frequently asked questions
What is FDA product code FHW?
FHW is the FDA product code for device, impotence, mechanical/hydraulic. It is a Class III device, regulated under 21 CFR 876.3350 and reviewed by the Gastroenterology and Urology panel.
What device class is FHW?
Class III, regulation 21 CFR 876.3350. Typical premarket route: PMA.
Have FHW devices been recalled?
Yes: 20 product recalls across 4 recall events; the most recent began 2023-03-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FHW
- Run a recall and safety report across every FHW manufacturer
- Watch product code FHW 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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