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Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)

FDA UDI

Class II (US FDA UDI)

by Us Medical Innovations, Llc

Identity

Trade Name
Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm) FDA UDI
Generic Name
Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI
Device Name
The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. The device is used to ablate soft tissue. FDA UDI
Model / Reference
CP-41110 FDA UDI
Description
The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. The device is used to ablate soft tissue. FDA UDI

Identifiers

Primary DI / UDI-DI
B413CP411100 FDA UDI
510(k) Number
K240297 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced open-surgery electrosurgical electrode, reusable 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Inert gas-enhanced open-surgery electrosurgical electrode, reusable

Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm) by Us Medical Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Inert gas-enhanced open-surgery electrosurgical electrode, reusable.

Cleared under the same submission

K240297 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Us Medical Innovations, Llc

Sources (1)

  • FDA UDI 570c5add-3db3-4731-b176-e84e55fcbdf4 34 fields · synced May 30, 2026