FDA.reportPublic FDA data

SynchroWave Antenna Kit

Primary DI
00851551005088
Brand
SynchroWave Antenna Kit
Company
PERSEON CORPORATION
Model
SWST-1415
Catalog number
SWST-1415
Device description
15cm Short Tip Antenna and Cooling Circuit
Published
2017-08-19
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

Contact Domains#

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
K141785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141785000MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIESBsd Medical Corp.2015-03-31NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851551005088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851551005088008515510050888515510050880851551005088

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-15 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
801-921-5555support@perseonmedical.com

Regulatory Flags#

DUNS number
080414615
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851551005002MicroThermX Microwave Ablation SystemMTX-180MTX-1802017-08-19
00851551005019MicroThermX Microwave Ablation SystemMTX-180-T2MTX-180-T22017-08-19
00851551005064SynchroWave Antenna KitSW-1415SW-14152017-08-19
00851551005071SynchroWave Antenna KitSW-1420SW-14202017-08-19
00851551005095SynchroWave Antenna KitSWST-1420SWST-14202017-08-19
00851551005156SynchroWave Antenna KitSW-1425SW-14252017-08-19

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