Clearance Summary
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES received FDA 510(k) clearance under submission number K993777, sponsored by R-Group Intl.. 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 2000-05-25.
- Submission: K993777
- Applicant / Sponsor: R-Group Intl.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 2000-05-25
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.