Model: H78720300351US0
Catalog: 20300351US
DI: 15051684030069
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
NanoKnife Generator 3.5
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bf260cae-b7b2-4ac1-8368-b80acf03006a
Distribution Status:
In Commercial Distribution
DUNS Number:
079252781
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
15051684030069
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58836
Name: Irreversible electroporation system
Definition:
A mobile assembly of devices designed to apply a series of microsecond electrical pulses to tissue to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. The system typically consists of both a mains electricity (AC-powered) computerized current generator with user interface and controls (e.g., foot-switch), and additional necessary components such as electrocardiogram (ECG) trigger monitor and sterile needle-like electrode probes. It is intended for the nonthermal surgical ablation of soft-tissues (e.g., tumours, endothelium).
FDA Product Codes
OAB
Low energy direct current thermal ablation system
Premarket Submissions
Submission Number:
K253198
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
90
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Storage Environment Atmospheric Pressure