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510(k) K042457

URO PRO by W.O.M. World of Medicine AG — Product Code LJH

K042457 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine AG for the device "URO PRO". The FDA issued a decision of Substantially Equivalent on October 25, 2004. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. W.O.M. World of Medicine AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2004
Date Received
September 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Irrigation, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
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 LJH

  • K162992 — Karl Storz UROMAT E.A.S.I. (July 7, 2017)
  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 2007)
  • K063700 — SPYGLASS IRRIGATION SYSTEM (February 8, 2007)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K010122 — CONTINUOUS FLOW Y-TUBING (June 4, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)

FDA data resources