Clearance Summary
E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES received FDA 510(k) clearance under submission number K921885, sponsored by Valleylab, 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 1994-03-25.
- Submission: K921885
- Applicant / Sponsor: Valleylab, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5390
- Decision date: 1994-03-25
Classification & Regulation
This clearance is catalogued under FDA product code HGZ and 21 CFR 884.5390, within the Obstetrics/Gynecology review panel as a Class II device.