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510(k) K822743

SOLID STATE CONTINUOUS FLOW CONTROL by Widran Urological Group, Ltd. — Product Code LJH

K822743 is an FDA 510(k) premarket notification submitted by Widran Urological Group, Ltd. for the device "SOLID STATE CONTINUOUS FLOW CONTROL". The FDA issued a decision of Substantially Equivalent on September 24, 1982. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Widran Urological Group, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1982
Date Received
September 10, 1982
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 Widran Urological Group, Ltd.

  • K861460 — SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (May 2, 1986)

Other clearances for product code LJH

  • K254111 — Irrigation/Urology Sets (September 10, 2026)
  • 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)

FDA data resources