| Device |
kit, catheter, cystostomy, suprapubic |
| Regulation Description |
Suprapubic urological catheter and accessories. |
| Definition |
Suprapubic cystostomy catheter kit. |
| Physical State |
Suprapubic Cystostomy Catheter Kit |
| Technical Method |
Suprapubic Cystostomy Catheter Kit |
| Target Area |
Suprapubic Cystostomy Catheter Kit |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | NWP |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5090
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Convenience Kits Interim Regulatory Guidance
|
|
| Third Party Review |
Not Third Party Eligible |
