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510(k) K133799

THERMEDX FLUID MANAGMENT SYSTEM by Thermedx, LLC — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2014
Date Received
December 13, 2013
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 Thermedx, LLC

  • K210628 — X-FLO Fluid Management System (November 4, 2021)
  • K172048 — FluidSmart (September 5, 2017)
  • K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH2 (March 25, 2011)
  • K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (July 23, 2010)

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)
  • 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)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)