Clearance Summary
Endomat Select received FDA 510(k) clearance under submission number K180735, sponsored by Karl Storz SE & CO. KG. 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 2018-10-31.
- Submission: K180735
- Applicant / Sponsor: Karl Storz SE & CO. KG
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 2018-10-31
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.