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510(k) K943031

BIPOLAR ELECTROSURGICAL PENCIL by Boston Surgical Products, Inc. — Product Code HQO

K943031 is an FDA 510(k) premarket notification submitted by Boston Surgical Products, Inc. for the device "BIPOLAR ELECTROSURGICAL PENCIL". The FDA issued a decision of Substantially Equivalent on September 23, 1994. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Boston Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1994
Date Received
June 27, 1994
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 Boston Surgical Products, Inc.

  • K972311 — MODEL 20 BIPOLAR COAGULATOR (September 18, 1997)
  • K972350 — MODEL 50 BIPOLAR COAGULATOR (August 21, 1997)
  • K944947 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS (July 28, 1995)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950375 — DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR (June 14, 1995)
  • K951912 — DISOPOSABLE & RESUABLE MONPOLAR CORD (May 12, 1995)
  • K951269 — DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL (April 24, 1995)
  • K950877 — REUSABLE MONOPOLAR FORCEPS (March 9, 1995)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K945893 — DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE (December 13, 1994)

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)
  • 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