Clearance Summary
COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES received FDA 510(k) clearance under submission number K933768, sponsored by Mahe-Medizintechnik. 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 1994-06-27.
- Submission: K933768
- Applicant / Sponsor: Mahe-Medizintechnik
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1994-06-27
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.