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510(k) K220472

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2022
Date Received
February 18, 2022
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)
  • 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)

Other clearances for product code NEY

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  • K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (August 8, 2025)
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  • K240518 — swiftPro™ System (April 23, 2024)
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