| Device Type ID | 1929 |
| Device Name | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| 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 | GCA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1929 |
| Device | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Product Code | GCA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Biliary Catheter And Accessories. |
| CFR Regulation Number | 876.5010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
| Device Problems | |
|---|---|
Material Protrusion / Extrusion | 18 |
Material Separation | 16 |
Deflation Problem | 14 |
Difficult To Remove | 9 |
Leak / Splash | 9 |
Fluid Leak | 9 |
Break | 8 |
Burst Container Or Vessel | 6 |
Material Fragmentation | 5 |
Detachment Of Device Component | 4 |
Detachment Of Device Or Device Component | 4 |
Device Operates Differently Than Expected | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Catheter | 2 |
Difficult To Insert | 2 |
Fitting Problem | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Material Deformation | 1 |
Sticking | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Separation Failure | 1 |
Moisture Or Humidity Problem | 1 |
Crack | 1 |
Shelf Life Exceeded | 1 |
Split | 1 |
Appropriate Term/Code Not Available | 1 |
Unintended Ejection | 1 |
Retraction Problem | 1 |
Use Of Device Problem | 1 |
Obstruction Of Flow | 1 |
Calcified | 1 |
Fracture | 1 |
Physical Resistance | 1 |
Wrinkled | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 135 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |