Clearance Summary
ENDOPLUS hand-held laparoscopic instruments received FDA 510(k) clearance under submission number K151567, sponsored by Endoplus. 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 2015-12-23.
- Submission: K151567
- Applicant / Sponsor: Endoplus
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 2015-12-23
Classification & Regulation
This clearance is catalogued under FDA product code HFI and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.