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HelixAR

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
HelixAR FDA UDI
Generic Name
Inert gas-enhanced electrosurgical system FDA UDI
Device Name
HelixAR 100 - 240 VAC 50/60 Hz Electrosurgical Unit with Argon Beam Coagulator FDA UDI
Model / Reference
60-8800-001 FDA UDI
Description
HelixAR 100 - 240 VAC 50/60 Hz Electrosurgical Unit with Argon Beam Coagulator FDA UDI

Identifiers

Catalog Number
60-8800-001 FDA UDI
Primary DI / UDI-DI
30653405005531 FDA UDI
510(k) Number
K172671 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced electrosurgical system 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Inert gas-enhanced electrosurgical system

HelixAR by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced electrosurgical system.

Cleared under the same submission

K172671 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI 3b36ad4c-99f3-43e4-8529-4e4ae2a12764 37 fields · synced Jun 8, 2026