FDA.reportPublic FDA data

Microwave Ablation Antennas

Primary DI
06954414601565
Brand
Microwave Ablation Antennas
Company
Canyon Medical Inc.
Model
KY-2450B-3
Device description
Microwave Ablation Antennas
Published
2025-03-14
Public version status
New
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
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241825000Microwave Ablation AntennasCanyon Medical, Inc.2024-09-20NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414601565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414601565069544146015656954414601565

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia system applicator, intracorporealA component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527310648
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954414670110Polyvinyl Alcohol Embolic MicrospheresPB-1012026-02-26
06954414670127Polyvinyl Alcohol Embolic MicrospheresPB-1022026-02-26
06954414670134Polyvinyl Alcohol Embolic MicrospheresPB-1032026-02-26
06954414670141Polyvinyl Alcohol Embolic MicrospheresPB-2012026-02-26
06954414670158Polyvinyl Alcohol Embolic MicrospheresPB-2022026-02-26
06954414670165Polyvinyl Alcohol Embolic MicrospheresPB-2032026-02-26
06954414670172Polyvinyl Alcohol Embolic MicrospheresPB-4012026-02-26
06954414670189Polyvinyl Alcohol Embolic MicrospheresPB-4022026-02-26
06954414670196Polyvinyl Alcohol Embolic MicrospheresPB-4032026-02-26
06954414670202Polyvinyl Alcohol Embolic MicrospheresPB-6012026-02-26
06954414670219Polyvinyl Alcohol Embolic MicrospheresPB-6022026-02-26
06954414670226Polyvinyl Alcohol Embolic MicrospheresPB-6032026-02-26
06954414670233Polyvinyl Alcohol Embolic MicrospheresPB-8012026-02-26
06954414670240Polyvinyl Alcohol Embolic MicrospheresPB-8022026-02-26
06954414670257Polyvinyl Alcohol Embolic MicrospheresPB-8032026-02-26
06954414670264Polyvinyl Alcohol Embolic MicrospheresPB-10512026-02-26
06954414670271Polyvinyl Alcohol Embolic MicrospheresPB-10522026-02-26
06954414670288Polyvinyl Alcohol Embolic MicrospheresPB-10532026-02-26
06954414670295Polyvinyl Alcohol Embolic MicrospheresPW-1012026-02-26
06954414670301Polyvinyl Alcohol Embolic MicrospheresPW-1022026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14