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510(k) K212150

Exablate Prostate System by InSightec, Inc. — Product Code PLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
July 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class
Class II
Regulation Number
876.4340
Review Panel
GU
Submission Type

Prostate tissue ablation

Other clearances by InSightec, Inc.

  • K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V (October 30, 2023)

Other clearances for product code PLP

  • K251910 — Focal One® (November 19, 2025)
  • K240296 — Tulsa Pro System (Pad-105) (May 9, 2024)
  • K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V (October 30, 2023)
  • K230692 — TULSA-PRO System (September 20, 2023)
  • K211858 — TULSA-PRO System (September 6, 2022)
  • K202286 — Tulsa-Pro System (September 16, 2020)
  • K191200 — TULSA-PRO System (August 15, 2019)
  • K172721 — FOCAL ONE (June 7, 2018)
  • K172285 — Ablatherm Fusion (October 3, 2017)
  • K160942 — Sonablate (December 21, 2016)