FDA.reportPublic FDA data

NanoKnife

Primary DI
H787204001110
Brand
NanoKnife
Company
ANGIODYNAMICS, INC.
Model
20400111
Device description
NanoKnife Disposable Single Electrode 5 Probe Pack - Activation
Published
2022-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OABLow energy direct current thermal ablation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OABLow Energy Direct Current Thermal Ablation SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150089000
K183385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150089000NanoKnife SystemAngioDynamics, Inc.2015-06-18OAB
K183385000NanoKnife SystemAngiodynamics2019-06-18OAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787204001110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Irreversible electroporation systemA 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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936666557958CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557965CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557972CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557989CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666557996CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558009CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558016CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558023CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558030CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558047CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558054CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558061CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558078CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558085CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558092CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558108CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558115CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558122CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558139CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16936666558146CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652116CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652123CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652130CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
16937278652147CurawayZhejiang CuraWay Medical Technology Co., Ltd.OAB2026-05-31
06972304750834DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750770DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750787DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750794DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750800DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22
16972304750817DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.OAB2026-05-22