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510(k) K173489

GYN-Pump PH304 by W.O.M. World of Medicine GmbH — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2018
Date Received
November 13, 2017
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 GmbH

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  • K201361 — PNEUMOCLEAR (July 29, 2020)
  • K173311 — ARTHRO-Pump PA304 (May 9, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K170784 — PNEUMOCLEAR (May 15, 2017)
  • K163320 — LAP-Pump PP110 (March 21, 2017)
  • K153513 — Insufflator 50L FM134 (March 4, 2016)
  • K152109 — HD-Camera HDC1000 (October 13, 2015)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)

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)
  • 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)