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Avecure

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 14-15-LH-35

by Medwaves, Inc.

Identity

Trade Name
AveCure 14G Large Antenna Probe EUDAMED
Avecure FDA UDI
Generic Name
Microwave ablation system probe, non-powered FDA UDI
Device Name
AveCure 14G Large Antenna Probe EUDAMED
14Gauge, Large Antenna Probe, 15cm length FDA UDI
Model / Reference
14-15-LH-35 EUDAMEDFDA UDI
Description
14Gauge, Large Antenna Probe, 15cm length FDA UDI

Identifiers

Catalog Number
14-15-LH-35 FDA UDI
Primary DI / UDI-DI
D-008585840021415LH35ZJ9J EUDAMED
00858584002008 FDA UDI
Basic UDI-DI
B-008585840021415LH35ZJ9J 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
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.

Cleared under the same submission

K143203 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medwaves, Inc.

Sources (2)

  • FDA UDI 053b91d4-204d-412b-adbb-d537560bb5aa 35 fields · synced Jun 19, 2026
  • EUDAMED 972111c6-f9a4-4749-9a2f-d7174e6c9975 61 fields · synced Jun 19, 2026