Home / 510(k) Clearances / K160936

510(k) K160936

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2016
Date Received
April 4, 2016
Clearance Type
Special
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)
  • 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)
  • K150313 — Ablation Confirmation (July 9, 2015)

Other clearances for product code NEY

  • K252632 — Microwave Ablation Device (March 2, 2026)
  • K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II (March 2, 2026)
  • K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (August 8, 2025)
  • K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A) (September 26, 2024)
  • K241825 — Microwave Ablation Antennas (September 20, 2024)
  • K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave (July 19, 2024)
  • K240784 — Temperature Sensor Probe (ABL-18TP20) (May 29, 2024)
  • K240518 — swiftPro™ System (April 23, 2024)
  • K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Empr (March 28, 2024)
  • K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact (January 31, 2024)