ArC SMART

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name: ArC SMART FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: ARC SMART Argon Probe 2.3/220 is for exclusive use with the gi4000 Electrosurgical Unit. FDA UDI
Model / Reference: ArC SMART Probe FDA UDI
Description: ARC SMART Argon Probe 2.3/220 is for exclusive use with the gi4000 Electrosurgical Unit. FDA UDI

Identifiers

Catalog Number: G1140001 FDA UDI
Primary DI / UDI-DI: 00724995209087 FDA UDI
510(k) Number: K130983 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical return electrode, single-use 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

Category: Electrosurgical return electrode, single-use

ArC SMART by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical return electrode, single-use.

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Medline — MEDLINE INDUSTRIES, INC. · Class II
Blayco — Telic, S.A.U. · Class IIb
Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS · Class II
Bio Protech — BIO PROTECH USA, INC. · Class II

Cleared under the same submission

K130983 also covers:

ARC SMART — US Endoscopy
ArC SMART — US Endoscopy

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: US Endoscopy

Sources (1)

FDA UDI d60b4dbd-73f8-41da-ac60-3cd844eefb3a 37 fields · synced Jun 8, 2026