Clearance Summary
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA received FDA 510(k) clearance under submission number K132384, sponsored by Endosec Corporation. 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 2014-07-02.
- Submission: K132384
- Applicant / Sponsor: Endosec Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2014-07-02
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.