FOC — Bag, Urine Collection, Newborn Class II
FDA product code FOC covers "Bag, Urine Collection, Newborn", a Class II medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOC
- Device Class
- Class II
- Regulation Number
- 876.5250
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950176 | hollister | PREMIE U-BAG URINE SPECIMEN COLLECTOR | February 7, 1995 |
| K943752 | rimeco products | RIMECO MIDSTREAM URINE COLLECTOR | November 1, 1994 |
| K911329 | c.r. bard | BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE | May 28, 1991 |
| K771368 | cavitron | PORTABLE INFANT VENTILATOR | August 4, 1977 |