Clearance Summary
ENDOCERVICAL ELECTRODE # 2 received FDA 510(k) clearance under submission number K070877, sponsored by Modern Medical Equipment Mfg., Ltd.. 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 2007-07-27.
- Submission: K070877
- Applicant / Sponsor: Modern Medical Equipment Mfg., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 2007-07-27
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.