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510(k) K112642

AQUILEX FLUID CONTROL SYSTEM H112 by W.O.M. World of Medicine AG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2012
Date Received
September 12, 2011
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 W.O.M. World of Medicine AG

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  • K170784 — PNEUMOCLEAR (May 15, 2017)
  • K163320 — LAP-Pump PP110 (March 21, 2017)
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  • K152109 — HD-Camera HDC1000 (October 13, 2015)
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Other clearances for product code HIG

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  • 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)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)