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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 Generator 3.0 FDA UDI
Model / Reference
20300301US FDA UDI
Description
NanoKnife Generator 3.0 FDA UDI

Identifiers

Primary DI / UDI-DI
H78720300301US0 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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 3bd57ff6-a658-4ede-bbc2-c5f5baaa56b2 36 fields · synced Jun 20, 2026