Home / 510(k) Clearances / K022449

510(k) K022449

HYSTEREOSCOPY PUMP HM4 by W.O.M. World of Medicine AG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2003
Date Received
July 26, 2002
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

  • 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)