| Device Type ID | 1754 |
| Device Name | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Regulation Description | Urine Collector 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) Exempt |
| CFR Regulation Number | 876.5250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FCN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1754 |
| Device | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Product Code | FCN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Incomplete Or Missing Packaging | 3 |
Packaging Problem | 3 |
Misassembled | 3 |
No Flow | 3 |
Retraction Problem | 1 |
Obstruction Of Flow | 1 |
Difficult To Remove | 1 |
Kinked | 1 |
Device Markings / Labelling Problem | 1 |
Partial Blockage | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SteriGear, LLC | II | Jun-23-2014 |