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510(k) K040094

PIGGYBACK IRRIGATING SYSTEM by Kosin Technologies, LLC — Product Code LJH

K040094 is an FDA 510(k) premarket notification submitted by Kosin Technologies, LLC for the device "PIGGYBACK IRRIGATING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 2004. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2004
Date Received
January 16, 2004
Clearance Type
Abbreviated
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 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)
  • 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