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510(k) K023808

IRRIGATION SETS by International Medsurg Connection — Product Code LJH

K023808 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "IRRIGATION SETS". The FDA issued a decision of Substantially Equivalent on March 10, 2003. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. International Medsurg Connection has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2003
Date Received
November 14, 2002
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 International Medsurg Connection

  • K110656 — IMC BLOOD COLLECTION NEEDLE (August 18, 2011)
  • K110882 — IMC INSULIN SYRINGE (August 18, 2011)
  • K102584 — IMC HYPODERMIC NEEDLE (January 14, 2011)
  • K102969 — IMC PISTON SYRINGES (December 20, 2010)
  • K100991 — IMC SURGICAL DRAPE (October 5, 2010)
  • K100846 — IMC SURGICAL FACE MASK (August 16, 2010)
  • K100208 — IMC SURGICAL DRAPE (April 20, 2010)
  • K052169 — IMC SURGICAL DRAPES (November 17, 2005)
  • K042893 — UNDER BUTTOCKS DRAPE (March 11, 2005)
  • K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE (November 7, 2002)

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)
  • K042457 — URO PRO (October 25, 2004)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
  • 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