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510(k) K043155

STARION UNIVERSAL POWER SUPPLY (UPS) by Starion Instruments — Product Code HQO

K043155 is an FDA 510(k) premarket notification submitted by Starion Instruments for the device "STARION UNIVERSAL POWER SUPPLY (UPS)". The FDA issued a decision of Substantially Equivalent on December 9, 2004. 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
December 9, 2004
Date Received
November 15, 2004
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

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K062257 — STARION INSTRUMENTS THERMAL LITIGATING SHEARS (October 10, 2006)
  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K001262 — THERMAL CAUTERY FORCEPS (June 14, 2000)
  • K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (June 14, 2000)
  • K000296 — STARION CAUTERY HOOK (March 7, 2000)
  • K000250 — CAUTERY FORCEPS WITH FOOTSWITCH (March 7, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)

Other clearances for product code HQO

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • 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