NanoKnife

Basic Information

• Brand Name: NanoKnife
• Primary DI: H787203001010
• Version / Model: 20300101
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 079105071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2019-04-09
• Public Version Status: Update
• Public Device Record Key: 8ecc3330-0405-41d8-aad0-f42e8b74b7cc

Device Description

NanoKnife Generator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAB	Low energy direct current thermal ablation system	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58836	Irreversible electroporation system	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H787203001010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150089	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius