Device |
hemostatic device for endoscopic gastrointestinal use |
Regulation Description |
Hemostatic device for intraluminal gastrointestinal use. |
Definition |
Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means. |
Physical State |
Hygroscopic hemostatic agent and delivery device. |
Technical Method |
Proposed hemostatic mechanism of action is absorption of fluid. |
Target Area |
GI |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | QAU |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.4456
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |