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510(k) K070871

STARION UNIVERSAL POWER SUPPLY by Starion Instruments — Product Code HQO

K070871 is an FDA 510(k) premarket notification submitted by Starion Instruments for the device "STARION UNIVERSAL POWER SUPPLY". The FDA issued a decision of Substantially Equivalent on April 13, 2007. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Starion Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
March 29, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Starion Instruments

  • K062257 — STARION INSTRUMENTS THERMAL LITIGATING SHEARS (October 10, 2006)
  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (June 14, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K001262 — THERMAL CAUTERY FORCEPS (June 14, 2000)
  • K000250 — CAUTERY FORCEPS WITH FOOTSWITCH (March 7, 2000)
  • K000296 — STARION CAUTERY HOOK (March 7, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)

Other clearances for product code HQO

  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K943031 — BIPOLAR ELECTROSURGICAL PENCIL (September 23, 1994)
  • K900913 — ADLER DISPOSABLE BIPOLAR CORD (April 4, 1990)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K852075 — SITE-MALIS BIPOLAR COAGULATOR MODULE (August 20, 1985)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)

FDA data resources