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Kirwan

FDA UDI

Class II (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name
Kirwan FDA UDI
Generic Name
Electrosurgical system generator FDA UDI
Device Name
Aura 110/220V 20W Bipolar Coagulator With Footswitch FDA UDI
Model / Reference
26-2500 FDA UDI
Description
Aura 110/220V 20W Bipolar Coagulator With Footswitch FDA UDI

Identifiers

Primary DI / UDI-DI
00841019106976 FDA UDI
510(k) Number
K023482 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical system generator 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrosurgical system generator

Kirwan by Kirwan Surgical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system generator.

Cleared under the same submission

K023482 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kirwan Surgical Products Llc

Sources (1)

  • FDA UDI 643a9c10-2493-45fb-9c11-3168bba38a95 35 fields · synced May 30, 2026