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510(k) K000893

AC POWERED THERMAL CAUTERY UNIT by Starion Instruments — Product Code HQO

K000893 is an FDA 510(k) premarket notification submitted by Starion Instruments for the device "AC POWERED THERMAL CAUTERY UNIT". The FDA issued a decision of Substantially Equivalent on June 14, 2000. 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
June 14, 2000
Date Received
March 20, 2000
Clearance Type
Traditional
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)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K001262 — THERMAL CAUTERY FORCEPS (June 14, 2000)
  • K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (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

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 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