| Device Type ID | 2170 |
| Device Name | Prosthesis, Esophageal |
| 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 | ESW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2170 |
| Device | Prosthesis, Esophageal |
| Product Code | ESW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Prosthesis. |
| CFR Regulation Number | 878.3610 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK IRELAND LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Stent | 256 |
Activation, Positioning Or Separation Problem | 166 |
Break | 68 |
Migration Or Expulsion Of Device | 61 |
Activation Failure Including Expansion Failures | 53 |
Positioning Problem | 40 |
Fracture | 32 |
Difficult To Remove | 29 |
Suture | 28 |
Material Integrity Problem | 21 |
Positioning Failure | 20 |
Detachment Of Device Or Device Component | 15 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Cover | 14 |
Tip | 12 |
Catheter | 11 |
Material Deformation | 11 |
Premature Activation | 11 |
Insufficient Information | 10 |
Partial Blockage | 9 |
Migration | 9 |
Detachment Of Device Component | 6 |
Use Of Device Problem | 5 |
Activation Problem | 5 |
Unraveled Material | 5 |
Knotted | 4 |
Hole In Material | 4 |
Material Separation | 4 |
Device Issue | 4 |
Torn Material | 4 |
Kinked | 4 |
Delivery System Failure | 3 |
Material Perforation | 3 |
Appropriate Term/Code Not Available | 3 |
Component Missing | 2 |
Misfire | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Human-Device Interface Problem | 2 |
Bent | 2 |
Device Or Device Fragments Location Unknown | 2 |
Device Markings / Labelling Problem | 2 |
Flaked | 1 |
Malposition Of Device | 1 |
Device Packaging Compromised | 1 |
Expulsion | 1 |
Human Factors Issue | 1 |
Material Fragmentation | 1 |
Leak / Splash | 1 |
Delivery System Issue, No Description | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Deployer | 1 |
Tip Breakage | 1 |
Shaft | 1 |
Occlusion Within Device | 1 |
Obstruction Of Flow | 1 |
Structural Problem | 1 |
Seal | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 979 |