FDA-Device2023-04-19Class II

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Angiodynamics, Inc.
Hazard

Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

Sold states
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Affected count
10 boxes( 5 probes/box)
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2023

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