Clearance Summary
LOOP/SQUARE ELECTRODE received FDA 510(k) clearance under submission number K952030, sponsored by E & M Engineering, 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 1996-07-31.
- Submission: K952030
- Applicant / Sponsor: E & M Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1996-07-31
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.