| Device |
kit, catheter, external, male (excludes hiv testing) |
| Regulation Description |
Urological catheter and accessories. |
| Definition |
Male external catheterization kit (excludes hiv testing). |
| Physical State |
Male External Catheterization Kit (Excludes HIV Testing) |
| Technical Method |
Male External Catheterization Kit (Excludes HIV Testing) |
| Target Area |
Male External Catheterization Kit (Excludes HIV Testing) |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | NWQ |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5130
|
|---|
| 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 |
