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NanoKnife

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
NanoKnife FDA UDI
Generic Name
Irreversible electroporation system FDA UDI
Device Name
NanoKnife Disposable Single Electrode Probe FDA UDI
Model / Reference
20400110 FDA UDI
Description
NanoKnife Disposable Single Electrode Probe FDA UDI

Identifiers

Primary DI / UDI-DI
H787204001100 FDA UDI
510(k) Number
K183385 FDA UDI
FDA Product Code
OAB FDA UDI
GMDN Term
Irreversible electroporation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 25 Centimeter FDA UDI

Category: Irreversible electroporation system

NanoKnife by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Irreversible electroporation system.

Cleared under the same submission

K183385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI 0e0f871b-852b-4b6d-8f01-cea9bbb1d38f 37 fields · synced Jun 8, 2026