Clearance Summary
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE received FDA 510(k) clearance under submission number K923628, sponsored by Bruce Mclucas. 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 1994-02-22.
- Submission: K923628
- Applicant / Sponsor: Bruce Mclucas
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1994-02-22
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.