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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:GENERATOR, CART, MONO F/S, BI F/S FDA UDI
Model / Reference
60-8800-SYS FDA UDI
Description
HELIXAR:GENERATOR, CART, MONO F/S, BI F/S FDA UDI

Identifiers

Catalog Number
60-8800-SYS FDA UDI
Primary DI / UDI-DI
30653405000758 FDA UDI
510(k) Number
K152860 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

K152860 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 6b2f34bc-8ec8-4a7c-aa8c-e6b890c52b28 36 fields · synced May 30, 2026