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510(k) K231738

NEUWAVE™ Microwave Ablation System and Accessories by Neuwave Medical, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2023
Date Received
June 14, 2023
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)
  • 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)
  • K173756 — Certus 140 2.45GHz Ablation System (October 24, 2018)
  • 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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