| Device Type ID | 2172 |
| Device Name | Stent, Colonic, Metallic, Expandable |
| Regulation Description | Esophageal Prosthesis. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.3610 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2172 |
| Device | Stent, Colonic, Metallic, Expandable |
| Product Code | MQR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Prosthesis. |
| CFR Regulation Number | 878.3610 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
M.I. TECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
M.I.TECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Stent | 67 |
Activation, Positioning Or Separation Problem | 43 |
Insufficient Information | 25 |
Positioning Problem | 22 |
Delivery System Failure | 21 |
Premature Activation | 18 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Activation Failure Including Expansion Failures | 13 |
Break | 13 |
Catheter | 12 |
Migration Or Expulsion Of Device | 9 |
Difficult To Remove | 9 |
Material Deformation | 8 |
Kinked | 4 |
Fracture | 3 |
Occlusion Within Device | 3 |
Unraveled Material | 2 |
Obstruction Of Flow | 2 |
Material Perforation | 2 |
Detachment Of Device Or Device Component | 2 |
Defective Device | 1 |
Mechanical Problem | 1 |
Detachment Of Device Component | 1 |
Positioning Failure | 1 |
Material Separation | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Shaft | 1 |
Bent | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 306 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SPS Sterilization, Inc | II | Sep-13-2018 |