Definition: A Benign Stricture Biliary Stent System Is A Prescription Device Intended For Treatment Of Benign Biliary Strictures. Stents Are Intended To Be Left Indwelling For A Limited Amount Of Time And Subsequently Removed. The Device Consists Of A Metal Sten
| Device Type ID | 2109 |
| Device Name | Biliary Stent System For Benign Strictures |
| Physical State | Device Consists Of An Expandable Metal Stent And A Delivery Catheter |
| Technical Method | Maintains Biliary Duct Patency |
| Target Area | Bile Ducts |
| Regulation Description | Metallic Biliary Stent System For Benign Strictures. |
| 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 | 876.5011 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2109 |
| Device | Biliary Stent System For Benign Strictures |
| Product Code | PNB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Metallic Biliary Stent System For Benign Strictures. |
| CFR Regulation Number | 876.5011 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC | ||
GRANTED | 1 | |
BOSTON SCIENTIFIC CORP. | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Break | 35 |
Catheter | 30 |
Stent | 17 |
Difficult To Remove | 15 |
Positioning Failure | 11 |
Positioning Problem | 9 |
Material Deformation | 8 |
Migration | 7 |
Detachment Of Device Or Device Component | 6 |
Premature Activation | 4 |
Migration Or Expulsion Of Device | 4 |
Use Of Device Problem | 4 |
Obstruction Of Flow | 3 |
Difficult Or Delayed Positioning | 3 |
Activation Failure Including Expansion Failures | 3 |
Appropriate Term/Code Not Available | 2 |
Tip | 1 |
Activation, Positioning Or Separation Problem | 1 |
Human-Device Interface Problem | 1 |
Material Integrity Problem | 1 |
Defective Device | 1 |
Difficult To Advance | 1 |
Partial Blockage | 1 |
| Total Device Problems | 168 |