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510(k) K150089

NanoKnife System by AngioDynamics, Inc. — Product Code OAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2015
Date Received
January 16, 2015
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

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  • 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)
  • K102329 — NANOKNIFE SYSTEM (October 24, 2011)
  • K080202 — ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT (May 8, 2008)
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