Clearance Summary
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) received FDA 510(k) clearance under submission number K240886, sponsored by Hologic, Inc.. 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 2024-07-25.
- Submission: K240886
- Applicant / Sponsor: Hologic, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 2024-07-25
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.