Clearance Summary
VARICOSCREEN(TM) received FDA 510(k) clearance under submission number K900404, sponsored by Promedex, 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 1990-12-07.
- Submission: K900404
- Applicant / Sponsor: Promedex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2982
- Decision date: 1990-12-07
Classification & Regulation
This clearance is catalogued under FDA product code KYA and 21 CFR 884.2982, within the Obstetrics/Gynecology review panel as a Class I device.