Clearance Summary
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 received FDA 510(k) clearance under submission number K955093, sponsored by Utah Medical Products, 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 1996-04-29.
- Submission: K955093
- Applicant / Sponsor: Utah Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1996-04-29
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.