Emprint

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Emprint FDA UDI
Generic Name: Microwave ablation system probe, non-powered FDA UDI
Device Name: Long Percutaneous Antenna with Thermosphere (TM) Technology Large Spherical Ablation Zone - Reinforced Antenna FDA UDI
Model / Reference: CA30L2 FDA UDI
Description: Long Percutaneous Antenna with Thermosphere (TM) Technology Large Spherical Ablation Zone - Reinforced Antenna FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521806566 FDA UDI
510(k) Number: K163105 FDA UDI
FDA Product Code: NEY FDA UDI
GEI 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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 30 Centimeter FDA UDI

Category: Microwave ablation system probe, non-powered

Emprint by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
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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

K163105 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: Covidien LP

Sources (1)

FDA UDI af7716a8-8c36-4b95-8c12-3447cb14a078 37 fields · synced May 30, 2026