Clearance Summary
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP received FDA 510(k) clearance under submission number K130059, sponsored by Ibi Israel Biomedical Innovations , 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 2013-07-29.
- Submission: K130059
- Applicant / Sponsor: Ibi Israel Biomedical Innovations , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2013-07-29
Classification & Regulation
This clearance is catalogued under FDA product code PBQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.