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510(k) K260976

NeuroBlate System by Monteris Medical — Product Code ONO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2026
Date Received
March 24, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Laser With Mr Thermography
Device Class
Class II
Regulation Number
878.4810
Review Panel
NE
Submission Type

Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.

Other clearances by Monteris Medical

  • K240877 — Monteris Medical NeuroBlate System (June 4, 2024)
  • K231061 — NeuroBlate System (December 8, 2023)
  • K222983 — NeuroBlate Fusion-S Software V3.17 (March 15, 2023)
  • K201056 — NeuroBlate System (August 21, 2020)
  • K193375 — NeuroBlate System (January 3, 2020)
  • K182036 — NeuroBlate System (October 15, 2018)
  • K173305 — NeuroBlate System (November 17, 2017)
  • K172881 — NeuroBlate System (October 20, 2017)
  • K171255 — Monteris Medical NeuroBlate System (July 25, 2017)
  • K170724 — NeuroBlate System (April 7, 2017)

Other clearances for product code ONO

  • K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
  • K251298 — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (September 4, 2025)
  • K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
  • K240877 — Monteris Medical NeuroBlate System (June 4, 2024)
  • K214125 — TRANBERG Thermoguide Therapy System (September 22, 2022)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)