Home / 510(k) Clearances / K063700

510(k) K063700

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

K063700 is an FDA 510(k) premarket notification submitted by Medical Scientific, Inc. for the device "SPYGLASS IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Medical Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2007
Date Received
December 13, 2006
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 Medical Scientific, Inc.

  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 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)
  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 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)

FDA data resources