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510(k) K090202

NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 by Ncontact Surgical, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2009
Date Received
January 27, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Other clearances by Ncontact Surgical, Inc.

  • K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (October 28, 2014)
  • K120857 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (November 13, 2012)
  • K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK (December 30, 2008)
  • K071819 — NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 (July 26, 2007)
  • K062539 — NCONTACT COAGULATION SYSTEM KIT (December 1, 2006)
  • K063012 — NCONTACT COAGULATION SYSTEM KIT, MODEL CSK (December 1, 2006)

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