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510(k) K062551

NEXUS IRRIGATION TUBING SET by Nexus Medical, LLC — Product Code LJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2006
Date Received
August 30, 2006
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

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  • K113398 — NEXUS TKO-6, LUER-ACTIVATED DEVICE (April 18, 2012)
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  • K092930 — NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED (March 10, 2010)
  • K092527 — NEXUS INJECTION SITE, MODEL NIS-8 (February 4, 2010)
  • K081123 — NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (November 14, 2008)
  • K080976 — NEXUS I.V. FLUID TRANSFER DEVICE (November 10, 2008)

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)
  • K042457 — URO PRO (October 25, 2004)
  • 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)