Home / 510(k) Clearances / K010607

510(k) K010607

MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 by Benlan, Inc. — Product Code LJH

K010607 is an FDA 510(k) premarket notification submitted by Benlan, Inc. for the device "MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001". The FDA issued a decision of Substantially Equivalent on November 28, 2001. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Benlan, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2001
Date Received
March 1, 2001
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 Benlan, Inc.

  • K131183 — MED-RX ORAL/ENTERAL SYRINGE (June 3, 2014)
  • K120375 — MED-RX PATIENT DELIVERY SET (June 28, 2012)
  • K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR (December 23, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS (November 8, 2010)
  • K990777 — MED-RX EXTENSION SETS (August 25, 1999)

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)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K010122 — CONTINUOUS FLOW Y-TUBING (June 4, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)

FDA data resources