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 Hem
| Device Type ID | 5906 |
| Device Name | Hemostatic Device For Endoscopic Gastrointestinal Use |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4456 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5906 |
| Device | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Product Code | QAU |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4456 [🔎] |
| Device Problems | |
|---|---|
Failure To Fire | 42 |
Complete Blockage | 17 |
Positioning Failure | 16 |
Obstruction Of Flow | 12 |
Improper Or Incorrect Procedure Or Method | 10 |
Use Of Device Problem | 8 |
Gas Leak | 5 |
Device Operates Differently Than Expected | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Deformation Due To Compressive Stress | 1 |
Fracture | 1 |
Human-Device Interface Problem | 1 |
Patient Device Interaction Problem | 1 |
Partial Blockage | 1 |
| Total Device Problems | 121 |