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510(k) K971538

MENTOR GEMINI HEMOSTATIC ERASER by Mentor Ophthalmics, Inc. — Product Code HQO

K971538 is an FDA 510(k) premarket notification submitted by Mentor Ophthalmics, Inc. for the device "MENTOR GEMINI HEMOSTATIC ERASER". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Mentor Ophthalmics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1997
Date Received
April 28, 1997
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 Mentor Ophthalmics, Inc.

  • K973146 — MENTOR SUPER ABSORBENT DRAPE (December 4, 1997)
  • K964312 — MENTOR TONO-PEN 3 (November 26, 1996)
  • K960765 — MENTOR ADVENT A/B SYSTEM (August 8, 1996)

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)
  • 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