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510(k) K002341

THERMAL CAUTERY UNIT, MODEL 150 by Geiger Medical Technologies, Inc. — Product Code HQO

K002341 is an FDA 510(k) premarket notification submitted by Geiger Medical Technologies, Inc. for the device "THERMAL CAUTERY UNIT, MODEL 150". The FDA issued a decision of Substantially Equivalent on October 23, 2000. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Geiger Medical Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2000
Date Received
August 1, 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 Geiger Medical Technologies, Inc.

  • K001029 — GEIGER NEEDLE ADAPTER, MODEL 406 (May 23, 2000)
  • K994075 — GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 (December 27, 1999)
  • K992149 — GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 (August 19, 1999)
  • K983852 — BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 (January 28, 1999)

Other clearances for product code HQO

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • 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