Clearance Summary
Smart External Drain (SED) System received FDA 510(k) clearance under submission number K171586, sponsored by Aqueduct Critical Care, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-06-30.
- Submission: K171586
- Applicant / Sponsor: Aqueduct Critical Care, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 2017-06-30
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.