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510(k) K980808

ENDO FMS UROLOGY by Future Medical Systems, Inc. — Product Code LJH

K980808 is an FDA 510(k) premarket notification submitted by Future Medical Systems, Inc. for the device "ENDO FMS UROLOGY". The FDA issued a decision of Substantially Equivalent on May 8, 1998. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Future Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1998
Date Received
March 3, 1998
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 Future Medical Systems, Inc.

  • K041824 — X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM (January 7, 2005)
  • K024185 — BIODHOC (January 15, 2004)
  • K023963 — ADHOC CLAW (May 5, 2003)
  • K021030 — TITANIUM CANNULATED INTERFERENCE SCREW (June 25, 2002)
  • K013685 — PLLA CANNULATED INTERFERENCE SCREW (January 18, 2002)
  • K002040 — FMS SOLO (September 11, 2000)
  • K955500 — FMS ARTHOPROBE (February 5, 1996)
  • K954465 — FMS DUO (November 9, 1995)
  • K954217 — ARTHROPLAST & ARTHRO-CUTTER (October 23, 1995)
  • K951843 — REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT (July 14, 1995)

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