FDA.reportPublic FDA data

US Medical Innovations

Primary DI
B413XL1000CP0
Brand
US Medical Innovations
Company
US MEDICAL INNOVATIONS, LLC
Model
XL-1000CP
Catalog number
XL-1000CP
Device description
Canady Helios Cold Plasma Ablation System
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
OABLow Energy Direct Current Thermal Ablation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
OABLow Energy Direct Current Thermal Ablation SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240297000Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC2024-05-03OAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B413XL1000CP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

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
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
B413PB4225550Canady Hybrid Plasma Paddle BladePB-4225552018-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26