FDA Registration
Active
🇺🇸 United States
ENDOSOUND INC
Reg #: 3017968993
·
FEI: 3017968993
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ENDOSOUND INC
- Registration Number
- 3017968993
- FEI Number
- 3017968993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4640 S Macadam Ave, Ste 200
- City
- Portland
- State
- OR
- ZIP
- 97239
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232518
Owner / Operator
- Firm Name
- EndoSound Inc
- Operator Number
- 10089762
- Address
- 4640 S Macadam Ave, Ste 200
- City
- Portland
- State
- OR
- Postal Code
- 97239
- Country
- US
- Correspondent
- Patrick Herriman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2024-01-18 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2024-01-05 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-01-05 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-01-05 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-01-05 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2025-12-16 |
Proprietary Names
Air Leakage Tester
EndoSound Vision System
Biopsy Port Adapter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device