FDA.reportPublic FDA data

Sonachill

Primary DI
00868108000274
Brand
Sonachill
Company
FOCUS SURGERY INC
Model
102-17000-0007
Device description
System used to regulate temperature and oxygen content of sterile water for a procedure.
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLPHigh Intensity Ultrasound System For Prostate Tissue AblationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150011000
K160942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150011000Sonablate 450Sonacare Medical, LLC2015-10-09PLP
K160942000SonablateSonacare Medical, LLC2016-12-21PLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868108000274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868108000274008681080002748681080002740868108000274

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101084143
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071153125Sonablate Insertion Pack403-02200-0002-BG403-14500-0003-BG2025-09-19
00850071153255Sonablate System711-17000-00092025-08-22
00850071153064Water Path KitE01020AST61-I2024-12-09
00850071153071Sonablate Insertion Pack403-02200-0014-I2024-12-09
00850071153088Water Path Kit403-02200-0020-I2024-12-09
00850071153095Sonablate Insertion Pack403-02200-0002-I2024-12-09
00868108000298Water Path Kit403-02200-00202024-12-09
00868108000205Water Path KitE01020AST612024-12-07
00850071153101O-ring Applicator Tool302-08119-10022024-12-02
00868108000281Sonablate Insertion Pack403-02200-00022024-12-02
00868108000267Sonablate Insertion Pack403-02200-00142017-03-24
00868108000212Sonasource102-17000-00092017-03-24
00868108000229Sonablate202-17000-00122017-03-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03661690000342Endorectal ProbeEDAP-TMS FRANCEPLP2026-01-26
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07540281001547TULSA-PROProfound Medical IncPLP2022-11-30
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07540281001684TULSA-PROProfound Medical IncPLP2022-11-30
07540281001691TULSA-PROProfound Medical IncPLP2022-11-30
07540281001615TULSA-PROProfound Medical IncPLP2022-11-24
07540281001370TULSA-PROProfound Medical IncPLP2022-09-23
07540281001400TULSA-PROProfound Medical IncPLP2022-09-23
07540281000816TULSA-PROProfound Medical IncPLP2022-05-26
07540281000823TULSA-PROProfound Medical IncPLP2022-05-26
07540281000830TULSA-PROProfound Medical IncPLP2022-05-26
07540281000847TULSA-PROProfound Medical IncPLP2022-05-26
07540281000908TULSA-PRO Profound Medical IncPLP2022-05-26
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07540281001233TULSA-PRO Profound Medical IncPLP2022-05-26
07540281001240TULSA-PROProfound Medical IncPLP2022-05-26