FDA.reportPublic FDA data

IntelliBlate Ximitry Probe Assembly, 13G x 15cm

Primary DI
00810563022292
Brand
IntelliBlate Ximitry Probe Assembly, 13G x 15cm
Company
Varian Medical Systems, Inc.
Model
IB-XPA-1315
Device description
IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1
Published
2024-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K240480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240480000IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.2024-07-19NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810563022299PackageGS13In Commercial Distribution
20810563022296PackageGS112In Commercial Distribution
00810563022292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081056302229910810563022299
2081056302229620810563022296
00810563022292008105630222928105630222920810563022292

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probe, electrically-poweredAn active, 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, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation) and/or thermocouple(s) to help control the temperature of the probe. The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), non-surgically invasive and open surgery procedures to ablate tissues. This is a single-use device.

Regulatory Flags#

DUNS number
118097024
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00810563020908TempProbe™ DeviceDP40-0015-213CRYO-55-F2022-02-18
00810563020915Prostate Procedure Probe PackDP35-0965-101CRYO-204-V2022-02-18
00810563020939Prostate Procedure Probe PackDP35-0595-108CRYO-207-V2022-02-18
008105630209608mm CryoprobeDP35-0215-102CRYO-48-F2022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0902-101CVA24002022-02-18

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