| Device |
endoscopic ultrasound system, gastroenterology-urology |
| Regulation Description |
Endoscope and accessories. |
| Definition |
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. |
| Physical State |
ultrasound system and system accessories, endoscope |
| Technical Method |
Uses ultrasound to visualize body cavities through endoscope |
| Target Area |
various body cavities, hollow organs, and canals in GI and GU tract |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ODG |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
|
|
| Third Party Review |
Not Third Party Eligible |
