Extracorporeal Shock Wave Lithotripter

Primary DI
06974928350131
Brand
Extracorporeal Shock Wave Lithotripter
Company
Shenzhen Wikkon Precision Technologies Co., Ltd.
Model
U200
Device description
U200 ESWL system focuses shock waves into the body using ultrasound guidance to fragment urinary calculi (i.e kidney and ureteral stones). U200 system incorporates a shock wave generator, high voltage generator, control console, ultrasound system and patient table. Prior to treatment, the stone is targeted using a stand-alone ultra-sound system. Shock waves are typically generated using electromagnetically repelled membranes. These shock waves are focused onto the stone with specially designed acoustic lens. The shock waves are created under water by the shock wave generator, and are transferred to the patient’s body through a water-filled silicon cushion. Once the stone is fragmented by the focused shock waves, the fragments pass out of the body with the patient’s urine. U200 system is available in stationary configuration, and are indicated for use in a single health care facility
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LNSLithotriptor, Extracorporeal Shock-Wave, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNSLithotriptor, Extracorporeal Shock-Wave, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242922000Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.2025-06-18LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974928350131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974928350131069749283501316974928350131

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical lithotripsy system, extracorporealAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543036260
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089800483ASADAL-M1Huons Meditech Co., Ltd.LNS2025-05-26
07630039101442MODULITH®Storz Medical AGLNS2025-04-11
07630039101459MODULITH®Storz Medical AGLNS2025-04-11
07630039101466MODULITH®Storz Medical AGLNS2025-04-11
06975438931018Extracorporeal Shock Wave LithotripterSuzhou Xixin Medical Instruments Co., Ltd.LNS2023-12-25
04049957006464Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
04049957006471Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
07630039100919MODULITH®Storz Medical AGLNS2021-04-13
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