Extracorporeal Shock Wave Lithotripter

GUDID 06974928350131

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

Shenzhen Wikkon Precision Technologies Co., Ltd.

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 06974928350131
• NIH Device Record Key: ff2f496e-c584-4c5a-895b-aac927a64923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extracorporeal Shock Wave Lithotripter
• Version Model Number: U200
• Company DUNS: 543036260
• Company Name: Shenzhen Wikkon Precision Technologies Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974928350131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242922

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30