| Device Type ID | 1753 |
| Device Name | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| 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 | FCM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1753 |
| Device | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Product Code | FCM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Product Quality Problem | 12 |
Patient-Device Incompatibility | 11 |
Incorrect Measurement | 5 |
Deflation Problem | 4 |
Inaccurate Flow Rate | 4 |
Leak / Splash | 4 |
Short Fill | 2 |
Device Damaged Prior To Use | 2 |
Sharp Edges | 1 |
Break | 1 |
Gel Leak | 1 |
Nonstandard Device | 1 |
Device Inoperable | 1 |
Device Operates Differently Than Expected | 1 |
Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Deformation Due To Compressive Stress | 1 |
No Flow | 1 |
Tip | 1 |
Misassembled | 1 |
| Total Device Problems | 58 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | III | Aug-06-2014 |