FDA product code FWM: Prosthesis, Breast, Inflatable, Internal, Saline
FWM is the FDA product code for prosthesis, breast, inflatable, internal, saline. It is a Class III device, regulated under 21 CFR 878.3530 and reviewed by the General and Plastic Surgery panel. Devices under FWM reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 9 recalls for FWM devices.
Definition
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Device class | Class III |
| Regulation | 21 CFR 878.3530 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
| Implant | Yes |
Recalls for FWM devices
9 product recalls in 8 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-09-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 3 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code FWM?
FWM is the FDA product code for prosthesis, breast, inflatable, internal, saline. It is a Class III device, regulated under 21 CFR 878.3530 and reviewed by the General and Plastic Surgery panel.
What device class is FWM?
Class III, regulation 21 CFR 878.3530. Typical premarket route: PMA.
Have FWM devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2021-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code FWM
- Run a recall and safety report across every FWM manufacturer
- Watch product code FWM 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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