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510(k) K173756

Certus 140 2.45GHz Ablation System by Neuwave Medical, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2018
Date Received
December 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Neuwave Medical, Inc.

  • K232227 — ABLATE-IQ (April 4, 2024)
  • K231738 — NEUWAVE™ Microwave Ablation System and Accessories (November 16, 2023)
  • K220472 — NEUWAVE Microwave Ablation System and Accessories (August 11, 2022)
  • K200081 — NEUWAVE Microwave Ablation System and Accessories (November 13, 2020)
  • K192427 — Ablation Confirmation (October 3, 2019)
  • K171022 — Ablation Confirmation (May 9, 2017)
  • K163118 — FLEX Microwave Ablation System and Accessories (March 9, 2017)
  • K161285 — Ablation Confirmation (June 29, 2016)
  • K160936 — Certus 140 2.45GHz Ablation System (May 4, 2016)
  • K150313 — Ablation Confirmation (July 9, 2015)

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