Clearance Summary
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM received FDA 510(k) clearance under submission number K032585, sponsored by Ron-Tech Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-01-09.
- Submission: K032585
- Applicant / Sponsor: Ron-Tech Medical , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2004-01-09
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.