Home / 510(k) Clearances / K031616

510(k) K031616

IUR FLUID MANAGEMENT SYSTEM by W.O.M. World of Medicine AG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2003
Date Received
May 23, 2003
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 W.O.M. World of Medicine AG

  • K250795 — PUREVUE™ FMS (December 5, 2025)
  • K201361 — PNEUMOCLEAR (July 29, 2020)
  • K173311 — ARTHRO-Pump PA304 (May 9, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 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)

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)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)