Device |
gastrointestinal tubes with enteral specific connectors |
Regulation Description |
Gastrointestinal tube and accessories. |
Definition |
To facilitate enteral specific connections. |
Physical State |
plastic connector |
Technical Method |
The connector is attached to an enteral tube and is intended to facilitate the administration of hydration, medication, and feed to a patient. |
Target Area |
the gastrointestinal tract |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | PIF |
Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5980
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |