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510(k) K233884

INUMI™ Flex Needle by Galvanize Therapeutics, Inc. — Product Code OAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2024
Date Received
December 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Low Energy Direct Current Thermal Ablation System
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Ablation of soft tissue

Other clearances by Galvanize Therapeutics, Inc.

  • K212871 — Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode (June 17, 2022)

Other clearances for product code OAB

  • K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Pro (December 6, 2024)
  • K240376 — Electroporation System (N3000) (October 4, 2024)
  • K240297 — Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (May 3, 2024)
  • K222001 — Irreversible Electroporation Ablation Generator, Irreversible Electroporation Pr (June 8, 2023)
  • K212871 — Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode (June 17, 2022)
  • K183385 — NanoKnife System (June 18, 2019)
  • K150089 — NanoKnife System (June 18, 2015)
  • K102329 — NANOKNIFE SYSTEM (October 24, 2011)
  • K080202 — ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT (May 8, 2008)
  • K080376 — ONCOBIONIC SYSTEM (April 2, 2008)