Home / 510(k) Clearances / K180825

510(k) K180825

Fluent Fluid Management System by Hologic, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2018
Date Received
March 30, 2018
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.

  • 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)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 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

  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • 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)
  • 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)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)