FDA.reportPublic FDA data

SynchroWave Antenna Kit

Primary DI
00810563020564
Brand
SynchroWave Antenna Kit
Company
Varian Medical Systems, Inc.
Model
SWST-1420
Catalog number
SWST-1420
Device description
20cm Short Tip Antenna and Cooling Circuit
Published
2019-03-27
Public version status
Update
Distribution status
Not 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
00810563020564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810563020564008105630205648105630205640810563020564

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
Length25Centimeter

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
8774672009customerservice@endocare.com

Regulatory Flags#

DUNS number
118097024
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
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029699Assembly module, CT/ MRGM11012910GM110129102025-05-16
00816389029743Retraction Nut CT/MRGM11012960GM110129602025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorGM11010740GM110107402024-11-19
00850800006074Vitesse5.0Vitesse 5.02024-11-01
00816389020245Crook Prostate Template for 2.0 mm needlesGM11012230GM110122302024-02-19
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointGM11009580GM110095802023-05-05
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointGM11009550GM110095502023-04-28
008105630220322.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
008105630220492.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
008105630220562.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
008105630220632.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmGM11013240GM110132402019-11-06
00816389021242Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry)AL13030001AL130300012016-09-19
00816389021297X-ray marker wire, 160 cm x 0.6, channel 1AL13116000AL131160002016-09-19
00816389021310X-ray marker wire, 160 cm x 0.6, channel 3AL13118000AL131180002016-09-19
00816389021747Central clamping mechanismGM11000860GM110008602016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmGM11000890GM110008902016-09-23
00816389021792Colpostats for 20mm spread, pairGM11000910GM110009102016-09-19

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