Clearance Summary
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 received FDA 510(k) clearance under submission number K013972, sponsored by Ackard Laboratories. 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 2001-12-17.
- Submission: K013972
- Applicant / Sponsor: Ackard Laboratories
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-12-17
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.