Catalog Number

-

Brand Name

NanoKnife

Version/Model Number

20400101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 26, 2021

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150089

Product Code

OAB

Product Code Name

Low energy direct current thermal ablation system

Public Device Record Key

767d1222-852e-4c28-b016-c33046abfe73

Public Version Date

October 27, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-