Home / 510(k) Clearances / K161285

510(k) K161285

Ablation Confirmation by Neuwave Medical, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2016
Date Received
May 9, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
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)
  • K160936 — Certus 140 2.45GHz Ablation System (May 4, 2016)
  • K150313 — Ablation Confirmation (July 9, 2015)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)