Neuwave

FDA UDI

Class II (US FDA UDI)

by NeuWave Medical, Inc.

Identity

Trade Name: NEUWAVE FDA UDI
Generic Name: Microwave ablation system probe, non-powered FDA UDI
Device Name: NEUWAVE Flex Probe 6 FDA UDI
Model / Reference: FLEX6 FDA UDI
Description: NEUWAVE Flex Probe 6 FDA UDI

Identifiers

Catalog Number: FLEX6 FDA UDI
Primary DI / UDI-DI: 00853719006326 FDA UDI
510(k) Number: K163118 FDA UDI
FDA Product Code: NEY FDA UDI
GMDN Term: Microwave ablation system probe, non-powered 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 150 Centimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

Category: Microwave ablation system probe, non-powered

Neuwave by NeuWave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microwave ablation system probe, non-powered.

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Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
SURGITRON 4.0 DUAL RF/90 IEC 220-240V — Cynosure, LLC · Class IIb
Swift® — Emblation , Ltd. · Class I
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb

Cleared under the same submission

K163118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NeuWave Medical, Inc.

Sources (1)

FDA UDI dcea22a3-6da2-46be-a2e5-8cd4ae71c470 38 fields · synced Jun 8, 2026