Canady Hybrid Plasma Scalpel

FDA UDI

Class II (US FDA UDI)

by Us Medical Innovations, Llc

Identity

Trade Name: Canady Hybrid Plasma Scalpel FDA UDI
Generic Name: Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI
Device Name: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue. FDA UDI
Model / Reference: AW-422552 FDA UDI
Description: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue. FDA UDI

Identifiers

Primary DI / UDI-DI: B413AW4225520 FDA UDI
510(k) Number: K113500 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: Not 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Canady Hybrid Plasma Scalpel by Us Medical Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K113500 also covers:

Canady Hybrid Plasma Paddle Blade — US MEDICAL INNOVATIONS, LLC

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 Medical Innovations, Llc

Sources (1)

FDA UDI 1093597a-c34f-4212-9bd9-d4dc5b2fa5ae 35 fields · synced Jun 8, 2026