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510(k) K945140

URO-FLO by Mallinckrodt Group, Inc. — Product Code LJH

K945140 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "URO-FLO". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1995
Date Received
October 20, 1994
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 Mallinckrodt Group, Inc.

  • K945053 — LF CT HIG PRESSURE CATHETERS (May 19, 1995)
  • K943581 — HYDRADJUST IV UROLOGICAL TABLE (January 4, 1995)
  • K943122 — SURGICAL DRAPES (September 7, 1994)
  • K934664 — HYDRAGOWN (May 24, 1994)
  • K920742 — HYDRAJUST IV UROLOGICAL TABLE (April 27, 1992)
  • K912944 — CT 8000 DIGITAL INJECTION SYSTEM (February 4, 1992)
  • K913264 — HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE (November 1, 1991)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)
  • K904147 — HUGH YOUNG II UROLOGICAL X-RAY SYSTEM (December 13, 1990)

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)
  • 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)

FDA data resources