FDA Registration
Inactive
🇺🇸 United States
PRODEON MEDICAL, INC.
·
Expires 2026
Products
2
Proprietary Names
2
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- PRODEON MEDICAL, INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2200 Zanker Rd Ste F
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252572
Owner / Operator
- Firm Name
- Prodeon Medical, Inc.
- Operator Number
- 10095509
- Address
- 2200 Zanker Road, Suite F
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Elaine Aplaon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2026-03-23 |
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | Class 2 | Gastroenterology, Urology | No | 2026-03-23 |
Proprietary Names
Prodeon Urethral Sheath System
Urocross Expander System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device