Clearance Summary
FEMALE URINARY INCONTINENCE SYS received FDA 510(k) clearance under submission number K843128, sponsored by Chesebrough-Pond'S U.S.A. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1985-01-02.
- Submission: K843128
- Applicant / Sponsor: Chesebrough-Pond'S U.S.A. Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1985-01-02
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.