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510(k) K071832

MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM by Medical Scientific, Inc. — Product Code LJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2007
Date Received
July 3, 2007
Clearance Type
Special
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 Medical Scientific, Inc.

  • K063700 — SPYGLASS IRRIGATION SYSTEM (February 8, 2007)
  • K031564 — CSS (October 7, 2003)
  • K011202 — MSI BIPOLAR SHEATH (December 31, 2001)
  • K981387 — EVANESCE SCAR MANAGEMENT SYSTEM (June 10, 1998)

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)
  • 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)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)