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510(k) K062551

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

K062551 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS IRRIGATION TUBING SET". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Nexus Medical, LLC has at least 10 other 510(k) clearances on record.

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

Other clearances by Nexus Medical, LLC

  • K142590 — All Safe Huber Safety Infusion Set (January 16, 2015)
  • K133351 — NEXUS NIS-6P LUER ACTIVATED DEVICE (May 22, 2014)
  • K130879 — NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS (July 9, 2013)
  • K130416 — NEXUS TKO-6P LUER ACTIVATED DEVICE (June 12, 2013)
  • K113398 — NEXUS TKO-6, LUER-ACTIVATED DEVICE (April 18, 2012)
  • K092382 — NEXUS PRESSURE RATED EXTENSION SETS (April 26, 2010)
  • 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)

FDA data resources