Data / Medical devices / Prosthesis, Penile
Prosthesis, Penile (FAE): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Prosthesis, Penile (product code FAE, Class 2, 21 CFR 876.3630). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on April 16, 2019, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FAE
- Device class
- 2
- Regulation
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Ireland | 2 |
| Turkey | 1 |
Makers of Prosthesis, Penile
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | April 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | April 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | April 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CLONMEL Tipperary, Ireland | Manufacturer | 1 | April 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer | 1 | October 29, 2004 | 0 | 1 | 0 | api.fda.gov |
| Rigicon AS | Bakirkoy Istanbul, Turkey | Manufacturer | 1 | April 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Rigicon, Inc. | Ronkonkoma, NY, United States | Repackager or relabeler, Specification developer | 1 | April 15, 2019 | 0 | 0 | 0 | api.fda.gov |
Updated April 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.