| Device Type ID | 1822 |
| Device Name | Stents, Drains And Dilators For The Biliary Ducts |
| Regulation Description | Biliary Catheter 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 | 876.5010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FGE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1822 |
| Device | Stents, Drains And Dilators For The Biliary Ducts |
| Product Code | FGE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Biliary Catheter And Accessories. |
| CFR Regulation Number | 876.5010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC | ||
SE - WITH LIMITATIONS | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SE - WITH LIMITATIONS | 3 | |
SUBSTANTIALLY EQUIVALENT | 7 | |
BOSTON SCIENTIFIC CORPORATION | ||
SE - WITH LIMITATIONS | 3 | |
SUBSTANTIALLY EQUIVALENT | 6 | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK IRELAND LTD | ||
SE - WITH LIMITATIONS | 2 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK IRELAND LTD. | ||
SE - WITH LIMITATIONS | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CORDIS CORP. | ||
SE - WITH LIMITATIONS | 1 | |
CORDIS CORPORATION | ||
SE - WITH LIMITATIONS | 1 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
M.I.TECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDINOL LTD. | ||
SE - WITH LIMITATIONS | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NAVILYST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.L. GORE & ASSOCIATES, INC. | ||
SE - WITH LIMITATIONS | 1 | |
W.L. GORE & ASSOCIATES,INC | ||
SE - WITH LIMITATIONS | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Stent | 1431 |
Material Rupture | 1162 |
Balloon | 1149 |
Break | 608 |
Catheter | 505 |
Adverse Event Without Identified Device Or Use Problem | 460 |
Activation, Positioning Or Separation Problem | 282 |
Device Dislodged Or Dislocated | 279 |
Migration Or Expulsion Of Device | 260 |
Material Deformation | 236 |
Fracture | 233 |
Difficult To Remove | 223 |
Kinked | 188 |
Detachment Of Device Or Device Component | 184 |
Detachment Of Device Component | 142 |
Difficult Or Delayed Positioning | 124 |
Occlusion Within Device | 118 |
Partial Blockage | 100 |
Premature Activation | 94 |
Burst Container Or Vessel | 91 |
Tip | 90 |
Material Puncture / Hole | 84 |
Bent | 71 |
Deflation Problem | 70 |
Device Subassembly | 65 |
Entrapment Of Device | 62 |
Difficult To Advance | 58 |
Positioning Failure | 58 |
Leak / Splash | 56 |
Positioning Problem | 54 |
Delivery System Failure | 54 |
Material Separation | 50 |
Unintended Movement | 47 |
Failure To Advance | 44 |
Calcified | 43 |
Defective Component | 42 |
Use Of Device Problem | 42 |
Activation Failure Including Expansion Failures | 36 |
Shaft | 35 |
Device Contamination With Chemical Or Other Material | 35 |
Device Damaged Prior To Use | 34 |
Inflation Problem | 34 |
Off-Label Use | 33 |
Hole In Material | 32 |
Torn Material | 22 |
Device Packaging Compromised | 21 |
Obstruction Of Flow | 21 |
Appropriate Term/Code Not Available | 21 |
Migration | 19 |
Improper Or Incorrect Procedure Or Method | 16 |
Device Markings / Labelling Problem | 16 |
Malposition Of Device | 15 |
Therapy Delivered To Incorrect Body Area | 15 |
Material Integrity Problem | 15 |
Suture | 15 |
Seal | 15 |
Material Frayed | 15 |
Contamination / Decontamination Problem | 15 |
Stretched | 14 |
Insufficient Information | 13 |
Crack | 13 |
Device Operates Differently Than Expected | 13 |
Tear, Rip Or Hole In Device Packaging | 13 |
Retraction Problem | 12 |
Cover | 12 |
Material Perforation | 11 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 10 |
Difficult To Insert | 10 |
Inaccurate Delivery | 9 |
Difficult To Position | 9 |
Label | 9 |
Component Missing | 8 |
Split | 8 |
Material Fragmentation | 8 |
Material Protrusion / Extrusion | 7 |
Device-Device Incompatibility | 7 |
Fluid Leak | 7 |
Failure To Adhere Or Bond | 7 |
Physical Resistance | 6 |
Structural Problem | 6 |
Difficult Or Delayed Activation | 6 |
Device Damaged By Another Device | 6 |
Separation Failure | 5 |
Unsealed Device Packaging | 5 |
Physical Resistance / Sticking | 5 |
Shelf Life Exceeded | 5 |
Defective Device | 5 |
Material Twisted / Bent | 5 |
Contamination During Use | 4 |
Device Deployer | 4 |
No Apparent Adverse Event | 4 |
Misfire | 4 |
Device Or Device Fragments Location Unknown | 4 |
Packaging Problem | 4 |
Inadequacy Of Device Shape And/or Size | 4 |
Dent In Material | 3 |
Mechanical Jam | 3 |
Locking Mechanism | 3 |
Guidewire | 3 |
Patient-Device Incompatibility | 2 |
| Total Device Problems | 9635 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Mar-14-2019 |
| 2 | Boston Scientific Corporation | II | Jul-01-2015 |
| 3 | Boston Scientific Corporation | II | Mar-31-2015 |
| 4 | Boston Scientific Corporation | II | Mar-27-2015 |
| 5 | Boston Scientific Corporation | II | Jan-10-2014 |
| 6 | Cook Inc. | II | Feb-28-2019 |
| 7 | Cook Medical Incorporated | II | Oct-31-2018 |
| 8 | Cordis Corporation | II | Jan-09-2018 |