NWO — Kit, Catheter, Urinary (Exludes Hiv Testing) Class II
FDA product code NWO covers "Kit, Catheter, Urinary (Exludes Hiv Testing)", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NWO
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Urinary Catheterization Kit (Excludes HIV Testing)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071496 | colorado catheter company | ICATH, STERILESURE | August 15, 2007 |