Clearance Summary
WORRY-REMOVER IRRIGATOR received FDA 510(k) clearance under submission number K030056, sponsored by Corisen Group, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2003-04-22.
- Submission: K030056
- Applicant / Sponsor: Corisen Group, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 2003-04-22
Classification & Regulation
This clearance is catalogued under FDA product code HED and 21 CFR 884.5900, within the Obstetrics/Gynecology review panel as a Class I device.