Clearance Summary
THE ADVANCE CATHETER FOR HSG AND SIS received FDA 510(k) clearance under submission number K123258, sponsored by Catheter Research, Inc.. 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 2013-01-31.
- Submission: K123258
- Applicant / Sponsor: Catheter Research, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2013-01-31
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.