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510(k) K832040

STERILE FLUID PRODUCING UNIT #EP550 by American Cystocope Makers, Inc. — Product Code LJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
June 24, 1983
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 American Cystocope Makers, Inc.

  • K812637 — ACMI BIPOLAR HEMOSTATIC SOURCE (October 26, 1981)
  • K811218 — ACMI ASPIRATOR KIT #8808 (July 1, 1981)
  • K803214 — ACMI BIPOLAR HEMOSTATIC ELECTRODE (January 15, 1981)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)
  • K760822 — MODEL TX-8 PANENDOSCOPE (October 21, 1976)
  • K760451 — AIR WATER SOURCE (ACMI MODEL 710) (August 30, 1976)
  • K760452 — COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) (August 30, 1976)

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)