Avecure

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 16-15-LH-15

by Medwaves, Inc.

Identity

Trade Name: AveCure 16G Small Antenna Probe EUDAMED
Avecure FDA UDI
Generic Name: Microwave ablation system probe, non-powered FDA UDI
Device Name: AveCure 16G Small Antenna Probe EUDAMED
16Gauge, Small Antenna Probe, 15cm length FDA UDI
Model / Reference: 16-15-LH-15 EUDAMEDFDA UDI
Description: 16Gauge, Small Antenna Probe, 15cm length FDA UDI

Identifiers

Catalog Number: 16-15-LH-15 FDA UDI
Primary DI / UDI-DI: D-008585840021615LH15395Y EUDAMED
00858584002053 FDA UDI
Basic UDI-DI: B-008585840021615LH15395Y EUDAMED
510(k) Number: K143203 FDA UDI
FDA Product Code: NEY FDA UDI
EMDN Code: K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Microwave ablation system probe, non-powered FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Category: Microwave ablation system probe, non-powered

Avecure by Medwaves, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
TempSure System, Surgical — Cynosure, LLC · Class IIb
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

K143203 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medwaves, Inc.

Sources (2)

FDA UDI cf411011-18ad-40c0-992b-740390d91063 35 fields · synced Jun 18, 2026
EUDAMED 86413f47-18e8-4db7-af27-035bcd6bccce 61 fields · synced Jun 18, 2026