Clearance Summary
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE received FDA 510(k) clearance under submission number K010365, sponsored by Personal Products 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 2001-04-30.
- Submission: K010365
- Applicant / Sponsor: Personal Products Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5160
- Decision date: 2001-04-30
Classification & Regulation
This clearance is catalogued under FDA product code MNG and 21 CFR 876.5160, within the Gastroenterology, Urology review panel as a Class I device.