| Device Type ID | 1952 |
| Device Name | Tube, Gastro-enterostomy |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KGC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1952 |
| Device | Tube, Gastro-enterostomy |
| Product Code | KGC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 107 |
Tube | 25 |
Leak / Splash | 18 |
Detachment Of Device Component | 16 |
Burst Container Or Vessel | 13 |
Detachment Of Device Or Device Component | 7 |
Occlusion Within Device | 6 |
Migration Or Expulsion Of Device | 5 |
Fluid Leak | 5 |
Complete Blockage | 5 |
Hole In Material | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Delivered As Unsterile Product | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Use Of Device Problem | 3 |
Suture | 3 |
Material Deformation | 3 |
Material Rupture | 3 |
Difficult To Advance | 2 |
Insufficient Information | 2 |
Failure To Infuse | 2 |
Material Separation | 2 |
Difficult To Remove | 2 |
Migration | 2 |
Wire | 2 |
Device Displays Incorrect Message | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Degraded | 1 |
Retraction Problem | 1 |
Unexpected Therapeutic Results | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
Infusion Or Flow Problem | 1 |
Material Disintegration | 1 |
Material Fragmentation | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Torn Material | 1 |
Split | 1 |
Crack | 1 |
Disconnection | 1 |
| Total Device Problems | 266 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corp | II | Dec-10-2015 |