| Device Type ID | 1718 |
| Device Name | Stent, Ureteral |
| Regulation Description | Ureteral Stent. |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FAD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1718 |
| Device | Stent, Ureteral |
| Product Code | FAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ureteral Stent. |
| CFR Regulation Number | 876.4620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COLOPLAST CORP | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 3 | |
SUBSTANTIALLY EQUIVALENT | 9 | |
PROMEPLA SAM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Q UROLOGICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Stent | 201 |
Break | 135 |
Difficult To Remove | 88 |
Calcified | 77 |
Material Separation | 55 |
Knotted | 31 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Migration Or Expulsion Of Device | 25 |
Device Damaged Prior To Use | 24 |
Kinked | 22 |
Catheter | 18 |
Fracture | 16 |
Occlusion Within Device | 14 |
Detachment Of Device Or Device Component | 13 |
Detachment Of Device Component | 13 |
Material Deformation | 12 |
Bent | 10 |
Device Operates Differently Than Expected | 10 |
Split | 9 |
Device Packaging Compromised | 8 |
Migration | 8 |
Tear, Rip Or Hole In Device Packaging | 7 |
Appropriate Term/Code Not Available | 7 |
Partial Blockage | 7 |
Biocompatibility | 7 |
Stretched | 6 |
Insufficient Information | 6 |
Torn Material | 5 |
Component(s), Broken | 4 |
Crack | 4 |
Malfunction | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Material Fragmentation | 4 |
Material Integrity Problem | 4 |
Defective Component | 3 |
Device Operational Issue | 3 |
Suture | 3 |
Material Disintegration | 3 |
Patient-Device Incompatibility | 3 |
Tip | 3 |
Obstruction Of Flow | 3 |
Deformation Due To Compressive Stress | 3 |
Device Dislodged Or Dislocated | 3 |
Material Frayed | 3 |
Out-Of-Box Failure | 3 |
Disconnection | 2 |
Entrapment Of Device | 2 |
Failure To Unfold Or Unwrap | 2 |
Packaging Problem | 2 |
Wire | 2 |
Activation, Positioning Or Separation Problem | 2 |
Device Component Or Accessory | 2 |
Contamination During Use | 2 |
Material Discolored | 2 |
Product Quality Problem | 2 |
Failure To Advance | 1 |
Uncoiled | 1 |
Wrinkled | 1 |
No Flow | 1 |
Cord | 1 |
Incorrect Measurement | 1 |
Use Of Device Problem | 1 |
Material Split, Cut Or Torn | 1 |
Seal | 1 |
Biofilm Coating In Device | 1 |
Unraveled Material | 1 |
Defective Device | 1 |
Difficult To Position | 1 |
Material Erosion | 1 |
Flaked | 1 |
Malposition Of Device | 1 |
Difficult To Advance | 1 |
Positioning Problem | 1 |
Unsealed Device Packaging | 1 |
Device Remains Implanted | 1 |
Ring | 1 |
Complete Blockage | 1 |
Accessory Incompatible | 1 |
Peeled / Delaminated | 1 |
Suture Line Separation | 1 |
Device, Removal Of (non-implant) | 1 |
Unintended Movement | 1 |
| Total Device Problems | 965 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Nov-14-2016 |
| 2 | Vance Products Incorporated | II | Jun-25-2015 |