Definition: Urinary Catheterization Kit (Excludes HIV Testing)
| Device Type ID | 2050 |
| Device Name | Kit, Catheter, Urinary (exludes Hiv Testing) |
| Physical State | Urinary Catheterization Kit (Excludes HIV Testing) |
| Technical Method | Urinary Catheterization Kit (Excludes HIV Testing) |
| Target Area | Urinary Catheterization Kit (Excludes HIV Testing) |
| 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 | NWO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2050 |
| Device | Kit, Catheter, Urinary (exludes Hiv Testing) |
| Product Code | NWO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
Deflation Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | II | Apr-14-2016 |
| 2 | Customed, Inc | II | Sep-03-2015 |
| 3 | Customed, Inc | I | Dec-16-2014 |