Agnes

FDA UDI

Class II (US FDA UDI)

by Agnes Medical Co., Ltd.

Identity

Trade Name: AGNES FDA UDI
Generic Name: Intradermal radio-frequency ablation system FDA UDI
Device Name: This is 1 set with following device AGNES: 1EA, GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA, GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EA GA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EA AG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA FDA UDI
Model / Reference: AGNES FDA UDI
Description: This is 1 set with following device AGNES: 1EA, GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA, GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EA GA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EA AG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA FDA UDI

Identifiers

Primary DI / UDI-DI: 18800067700009 FDA UDI
510(k) Number: K203013 FDA UDI
FDA Product Code: GEI FDA UDI
KCW FDA UDI
GMDN Term: Intradermal radio-frequency ablation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
878.5350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intradermal radio-frequency ablation system

Agnes by Agnes Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K203013 also covers:

AGNES — AGNES MEDICAL CO., LTD.
AGNES-S — AGNES MEDICAL CO., LTD.

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: Agnes Medical Co., Ltd.

Sources (1)

FDA UDI e2e7cce7-f5f3-4356-bd2c-d9e1ac4c5d25 36 fields · synced May 30, 2026