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)
FDA 510(k) clearance K240886 · decided 2024-07-25
Clearance details
- K-number
- K240886
- Device name
- 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)
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-01
- Decision date
- 2024-07-25
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Endomat Select (UP220) (K261706) | KARL STORZ SE & CO. KG | 2026-07-16 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |
| X-FLO Fluid Management System (K210628) | Thermedx, LLC | 2021-11-04 |
| Endomat Select, IBS Shaver Software, License (K201355) | Karl Storz SE & CO. KG | 2020-07-22 |
| Endomat Select (K180735) | Karl Storz SE & CO. KG | 2018-10-31 |
| Fluent Fluid Management System (K180825) | Hologic, Inc. | 2018-08-03 |
| GYN-Pump PH304 (K173489) | W.O.M. World of Medicine GmbH | 2018-03-28 |
| Aquilex Fluid Control System AQL-100S (K172040) | W.O.M. World of Medicine GmbH | 2018-02-05 |
| FluidSmart (K172048) | Thermedx, LLC | 2017-09-05 |
| THERMEDX FLUID MANAGMENT SYSTEM (K133799) | Thermedx, LLC | 2014-06-20 |
| HYSTEROSCOPY PUMP HM6 (K123732) | W.O.M. World of Medicine AG | 2013-04-04 |
| AQUILEX FLUID CONTROL SYSTEM H112 (K112642) | W.O.M. World of Medicine AG | 2012-02-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
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| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |