| Device Type ID | 1962 |
| Device Name | Accessories, Catheter, G-u |
| 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 | KNY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1962 |
| Device | Accessories, Catheter, G-u |
| Product Code | KNY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LEOMED, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROMEPLA SAM | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SOLACE THERAPEUTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 31 |
Tip | 12 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Insulation | 3 |
Split | 2 |
Packaging Problem | 1 |
Difficult To Insert | 1 |
Detachment Of Device Component | 1 |
Material Fragmentation | 1 |
Fracture | 1 |
Inflation Problem | 1 |
Device Operates Differently Than Expected | 1 |
Material Integrity Problem | 1 |
Material Frayed | 1 |
| Total Device Problems | 60 |