| Device Type ID | 1987 |
| Device Name | System, Irrigation, Urological |
| Regulation Description | Urological 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 | 876.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LJH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1987 |
| Device | System, Irrigation, Urological |
| Product Code | LJH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Tube | 24 |
Fluid Leak | 22 |
Connector | 21 |
Device Contamination With Chemical Or Other Material | 15 |
Disconnection | 14 |
Loose Or Intermittent Connection | 12 |
Device Operates Differently Than Expected | 8 |
Device Packaging Compromised | 7 |
Filter | 5 |
Leak / Splash | 4 |
Fitting Problem | 3 |
Clamp | 3 |
Hole In Material | 3 |
Packaging Problem | 3 |
Air Eliminator | 3 |
No Flow | 3 |
Component Missing | 2 |
Filling Problem | 2 |
Probe | 2 |
Out-Of-Box Failure | 2 |
Detachment Of Device Component | 2 |
Partial Blockage | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Break | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Cut In Material | 1 |
Improper Flow Or Infusion | 1 |
Failure To Disconnect | 1 |
Component Falling | 1 |
Regulator | 1 |
Delivered As Unsterile Product | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Cap | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 177 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hospira Inc. | II | May-16-2014 |
| 2 | Stryker Endoscopy | II | Jul-19-2014 |