Clearance Summary
EndoTool IV System received FDA 510(k) clearance under submission number K201619, sponsored by Monarch Medical Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2020-08-07.
- Submission: K201619
- Applicant / Sponsor: Monarch Medical Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2020-08-07
Classification & Regulation
This clearance is catalogued under FDA product code NDC and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.