FDA.reportPublic FDA data

Canady Hybrid Plasma Scalpel

Primary DI
B413AW4225540
Brand
Canady Hybrid Plasma Scalpel
Company
US MEDICAL INNOVATIONS, LLC
Model
AW-422554
Device description
The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.
Published
2018-03-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113500000CANADY VIEIRA HYBRID PLASMA SCALPELUs Medical Innovations, LLC2011-12-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B413AW4225540PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced open-surgery electrosurgical electrodeA rigid, invasive, distal component of an argon-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of argon (Ar) gas directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within an Ar gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961656951
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B413XL1000CP0US Medical InnovationsXL-1000CPXL-1000CP2024-06-24
B413CP411100Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)CP-411102024-05-09
B413XL10000US Medical InnovationsXL-1000XL10002020-01-10
B413AW4225380Canady Plasma GIT ProbeAW-4225382018-03-05
B413AW4225400Canady Plasma GIT Side Fire ProbeAW-4225402018-03-05
B413AW4225410Canady Plasma GIT Side Fire ProbeAW-4225412018-03-05
B413AW4225520Canady Hybrid Plasma ScalpelAW-4225522018-03-05
B413PB4225550Canady Hybrid Plasma Paddle BladePB-4225552018-03-05

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Primary DI, Brand, Company table
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