FDA.reportPublic FDA data

US Medical Innovations

Primary DI
B413XL10000
Brand
US Medical Innovations
Company
US MEDICAL INNOVATIONS, LLC
Model
XL-1000
Catalog number
XL1000
Device description
Canady Plasma SMART Electrosurgical Generator
Published
2020-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K192124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192124000Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC2019-11-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B413XL10000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced electrosurgical system generatorA mains electricity-powered (AC-powered) component of an argon-enhanced electrosurgical system that serves as a source of argon (Ar) gas and generates a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat in tissues for cutting and coagulating during surgery. The argon is delivered via this device and through a connected handpiece unit that ensures that the argon is channelled around the cutting electrode; a process which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961656951
Device count
1
Serial number
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
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
B413PB4225550Canady Hybrid Plasma Paddle BladePB-4225552018-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13