FDA.reportPublic FDA data

Canady Hybrid Plasma Paddle Blade

Primary DI
B413PB4225550
Brand
Canady Hybrid Plasma Paddle Blade
Company
US MEDICAL INNOVATIONS, LLC
Model
PB-422555
Device description
The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm bendable paddle blade tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.
Published
2018-03-05
Public version status
Update
Distribution status
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
B413PB4225550PrimaryHIBCC0

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
No natural rubber latex
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
B413AW4225540Canady Hybrid Plasma ScalpelAW-4225542018-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03