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510(k) K172048

FluidSmart by Thermedx, LLC — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2017
Date Received
July 6, 2017
Clearance Type
Special
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

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  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)
  • 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

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  • 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)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)