Clearance Summary
BURBANK TENACULUM, MODEL 09-0011-01 received FDA 510(k) clearance under submission number K030078, 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 2003-01-24.
- Submission: K030078
- 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: 2003-01-24
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.