| Device |
endoscopic access overtube, gastroenterology-urology |
| Regulation Description |
Endoscope and accessories. |
| Definition |
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation. |
| Physical State |
overtube |
| Technical Method |
Endoscope inserted and advanced through center of device |
| Target Area |
various openings in gi and gu tract |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | FED |
|---|
| 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 Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final
|
|
|
Third Party Review
|
Accredited Persons
|
