| Device Type ID | 5611 |
| Device Name | Catheter, Nephrostomy, General & Plastic Surgery |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5611 |
| Device | Catheter, Nephrostomy, General & Plastic Surgery |
| Product Code | GBO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 231 |
Material Separation | 93 |
Fluid Leak | 72 |
Break | 45 |
Difficult To Remove | 34 |
Detachment Of Device Or Device Component | 26 |
Fitting Problem | 25 |
Air Leak | 19 |
Catheter | 16 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Aspiration Issue | 9 |
Device Contamination With Chemical Or Other Material | 8 |
Detachment Of Device Component | 8 |
Material Integrity Problem | 8 |
Device Operates Differently Than Expected | 6 |
Migration Or Expulsion Of Device | 6 |
Crack | 6 |
Material Deformation | 5 |
Disconnection | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Connection Problem | 4 |
Occlusion Within Device | 3 |
Material Fragmentation | 3 |
Kinked | 2 |
Material Rupture | 2 |
Difficult To Advance | 2 |
Device Slipped | 2 |
Appropriate Term/Code Not Available | 2 |
Material Puncture / Hole | 2 |
Activation, Positioning Or Separation Problem | 2 |
Lock | 2 |
Tip Breakage | 1 |
Burst Container Or Vessel | 1 |
Fracture | 1 |
Material Twisted / Bent | 1 |
Suture | 1 |
Difficult To Open Or Close | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Material Perforation | 1 |
Filtration Problem | 1 |
Insufficient Information | 1 |
Component(s), Broken | 1 |
Hub | 1 |
Malposition Of Device | 1 |
Entrapment Of Device | 1 |
Difficult To Insert | 1 |
Hole In Material | 1 |
Complete Blockage | 1 |
Component Incompatible | 1 |
Positioning Failure | 1 |
Device Packaging Compromised | 1 |
Expulsion | 1 |
Mechanical Jam | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Suture Line Separation | 1 |
Strain Relief | 1 |
Partial Blockage | 1 |
| Total Device Problems | 686 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Mar-18-2018 |