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510(k) K151976

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode by Omnitech Systems, Inc. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2016
Date Received
July 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Omnitech Systems, Inc.

  • K050454 — OMNITECH FULGURATING ELECTRODE (May 27, 2005)
  • K981463 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE (July 17, 1998)
  • K981464 — OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (July 10, 1998)
  • K964365 — RESECTOSCOPE CUTTING LOOP ELECTRODE (April 22, 1997)
  • K965093 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE (March 19, 1997)

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