FDA.reportPublic FDA data

Dophi

Primary DI
16972304750268
Brand
Dophi
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
SS-MWA-1526C
Device description
Microwave Ablation Electrode Kits
Published
2022-01-19
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
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
K183153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183153000Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.2019-07-08NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972304750268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697230475026816972304750268

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probeA hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The probe includes a handle and an antenna, and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), and open surgery procedures to ablate tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550274579
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972304750407DeepEyeEVS1002026-05-22
06972304750414DeepEyeEVS2002026-05-22
06972304750834DophiNPG30002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
16972304750428DeepEyeLPS310002026-05-22
16972304750435DeepEyeLPS310302026-05-22
16972304750770DophiNSP132026-05-22
16972304750787DophiNSP182026-05-22
16972304750794DophiNSP252026-05-22
16972304750800DophiNTP132026-05-22
16972304750817DophiNTP182026-05-22
16972304750824DophiNTP252026-05-22
16972304750848DophiNFS062026-05-22
16972304751555InflaCureGI-S0012026-05-22
16972304750015DophiSS-TP18G-202022-01-19
06972304750209DophiR150E2022-03-07
06972304751411DophiSJ-A012022-03-07
16972304750022DophiSS-RFAS1-15102022-03-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060652910251SwiftipsEMBLATION LIMITEDNEY2026-06-08
05060652910268SwiftipsEMBLATION LIMITEDNEY2026-06-08
05060652910275SwiftipsEMBLATION LIMITEDNEY2026-06-08
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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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