NanoKnife System

Low Energy Direct Current Thermal Ablation System

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Nanoknife System.

Pre-market Notification Details

Device IDK150089
510k NumberK150089
Device Name:NanoKnife System
ClassificationLow Energy Direct Current Thermal Ablation System
Applicant ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough,  MA  01752
ContactSuzanne Goodman
CorrespondentSuzanne Goodman
ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough,  MA  01752
Product CodeOAB  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-16
Decision Date2015-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787204003015 K150089 000
H787203001010 K150089 000
H78720300101US0 K150089 000
H787204001015 K150089 000
H787204001025 K150089 000
H787204001030 K150089 000
H787204001035 K150089 000
H787204001040 K150089 000
H787204001045 K150089 000
H787204001050 K150089 000
H787204001055 K150089 000
H787204001060 K150089 000
H787204001065 K150089 000
H787204001070 K150089 000
H787204001080 K150089 000
15051684029643 K150089 000

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