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510(k) K240886

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) by Hologic, Inc. — Product Code HIG

K240886 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on July 25, 2024. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Hologic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2024
Date Received
April 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by Hologic, Inc.

  • K253634 — CoolSeal Generator® (CSL-200-90) (June 17, 2026)
  • K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
  • K251993 — Panther Fusion GI Expanded Bacterial Assay (September 25, 2025)
  • K243341 — Genius AI Detection 2.0 (July 31, 2025)
  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K243935 — Aptima CMV Quant Assay (January 17, 2025)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (November 15, 2024)
  • K233352 — Aptima HCV Quant Dx Assay (July 24, 2024)
  • K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (July 18, 2024)

Other clearances for product code HIG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K210628 — X-FLO Fluid Management System (November 4, 2021)
  • K201355 — Endomat Select, IBS Shaver Software, License (July 22, 2020)
  • K180735 — Endomat Select (October 31, 2018)
  • K180825 — Fluent Fluid Management System (August 3, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)

FDA data resources