Clearance Summary
BURBANK TENACULUM received FDA 510(k) clearance under submission number K060573, sponsored by Vascular Control Systems, Inc.. 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 2006-04-21.
- Submission: K060573
- Applicant / Sponsor: Vascular Control Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2006-04-21
Classification & Regulation
This clearance is catalogued under FDA product code HDC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.