| Device Type ID | 1992 |
| Device Name | Dislodger, Stone, Biliary |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LQR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1992 |
| Device | Dislodger, Stone, Biliary |
| Product Code | LQR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Biliary Catheter And Accessories. |
| CFR Regulation Number | 876.5010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 3 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 19 |
Wire | 9 |
Positioning Problem | 7 |
Material Separation | 3 |
Failure To Align | 2 |
Detachment Of Device Or Device Component | 2 |
Separation Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Balloon | 2 |
Deflation Problem | 1 |
Use Of Device Problem | 1 |
Catheter | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Material Integrity Problem | 1 |
Difficult To Advance | 1 |
Fitting Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 57 |