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510(k) K120857

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX by Ncontact Surgical, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2012
Date Received
March 21, 2012
Clearance Type
Traditional
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)
  • K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND (February 17, 2009)
  • 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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