Home / 510(k) Clearances / K242687

510(k) K242687

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) by AngioDynamics, Inc. — Product Code OAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2024
Date Received
September 6, 2024
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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