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510(k) K864904

3F ELECTRODE by Northgate Research, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
December 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by Northgate Research, Inc.

  • K903337 — 1.9 FRENCH LITHOTRIPTER ELECTRODE (November 16, 1990)
  • K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE (October 18, 1989)
  • K891254 — UROLOGICAL STONE BASKET (March 22, 1989)
  • K891253 — UROLOGICAL GRASPING FORCEPS (March 22, 1989)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K852874 — 5F ELECTRODE(LITHOTRIPTOR) (August 21, 1985)
  • K802322 — MODEL SD-1 DISINTEGRATOR (November 10, 1980)

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  • K230488 — EL27-Compact; Sterile EHL-Probes (August 31, 2023)
  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K162119 — UreTron PF Series Probe (August 29, 2016)
  • K160198 — UreTron MultiProbe Lithotripter System (February 23, 2016)
  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K123038 — SWISS LITHOBREAKER (January 16, 2013)