Clearance Summary
VACURECT VACUUM CONSTRICTION DEVICE received FDA 510(k) clearance under submission number K032776, sponsored by Vacurect Manufacturing (Pty) , Ltd.. 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 2003-10-03.
- Submission: K032776
- Applicant / Sponsor: Vacurect Manufacturing (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 2003-10-03
Classification & Regulation
This clearance is catalogued under FDA product code LKY and 21 CFR 876.5020, within the Gastroenterology, Urology review panel as a Class II device.