Clearance Summary
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE received FDA 510(k) clearance under submission number K952688, sponsored by Empi. 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 1995-12-06.
- Submission: K952688
- Applicant / Sponsor: Empi
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 1995-12-06
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.