FDA.reportPublic FDA data

Microwave Ablation Antennas

Primary DI
06954414674491
Brand
Microwave Ablation Antennas
Company
Canyon Medical Inc.
Model
KY-2450A-14
Device description
Microwave Ablation Antennas
Published
2025-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K261636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241825000Microwave Ablation AntennasCanyon Medical, Inc.2024-09-20NEY
K261636000Microwave Ablation AntennasCanyon Medical, Inc.2026-10-28NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414674491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414674491069544146744916954414674491

Regulatory Flags#

DUNS number
527310648
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954414601015Microwave Ablation AntennasKY-2ABP-11A2025-03-14
06954414601107Microwave Ablation AntennasKY-2450B-52025-03-14
06954414601121Microwave Ablation AntennasKY-2450B-132025-03-14
06954414601565Microwave Ablation AntennasKY-2450B-32025-03-14
06954414601572Microwave Ablation AntennasKY-2450B-42025-03-14
06954414601923Microwave Ablation AntennasKY-2450A-72025-03-14
06954414601930Microwave Ablation AntennasKY-2450A-112025-03-14
06954414674460Microwave Ablation AntennasKY-2450A-42025-03-14
06954414674477Microwave Ablation AntennasKY-2450A-52025-03-14
06954414674484Microwave Ablation AntennasKY-2450A-132025-03-14
06954414674507Microwave Ablation AntennasKY-2450A-152025-03-14
06954414674514Microwave Ablation AntennasKY-2450A-162025-03-14
06954414674521Microwave Ablation AntennasKY-2450A-172025-03-14
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

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Primary DI, Brand, Company table
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06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
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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