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510(k) K212871

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode by Galvanize Therapeutics, Inc. — Product Code OAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2022
Date Received
September 9, 2021
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.

  • K233884 — INUMI™ Flex Needle (May 22, 2024)

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)
  • K233884 — INUMI™ Flex Needle (May 22, 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)
  • 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)