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510(k) K900913

ADLER DISPOSABLE BIPOLAR CORD by Adler Instrument Co. — Product Code HQO

K900913 is an FDA 510(k) premarket notification submitted by Adler Instrument Co. for the device "ADLER DISPOSABLE BIPOLAR CORD". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Adler Instrument Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
February 27, 1990
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 Adler Instrument Co.

  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (December 21, 1990)
  • K903208 — MAXI-FLOW INSUFFLATOR TUBING SET (December 17, 1990)
  • K841723 — ADLER CUSTOM PROCEDURE PACKS (August 1, 1984)
  • K833264 — ADLER STEAM INDICATOR-GAS INDICATOR (November 3, 1983)
  • K831068 — CONTAINER SYSTEM (May 9, 1983)

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)
  • 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)
  • 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