Data / Medical devices / United States / Prodeon Medical, Inc.
Prodeon Medical, Inc.: FDA-registered device maker in San Jose, CA, United States, 3 510(k) clearances
Prodeon Medical, Inc. is registered with the FDA (registration 3045323889) in San Jose, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 22, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3045323889
- Address
- 2200 Zanker Rd Ste F, San Jose, CA, United States, 95131
- Owner or operator
- Prodeon Medical, Inc. (10095509)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 23, 2026
- Registered through
- 2027
- Brand names listed
- Prodeon Urethral Sheath System, Urocross Expander System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2026 | K261342 | Urocross Expander System (UES-2018-C1) | QKA | Substantially Equivalent | Prodeon Medical, Inc. | accessdata.fda.gov |
| March 12, 2026 | K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | QKA | Substantially Equivalent | Prodeon Medical, Inc. | accessdata.fda.gov |
| October 7, 2025 | K252572 | Prodeon Urethral Sheath System | FED | Substantially Equivalent | Prodeon Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
Updated June 22, 2026. 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.