Lithostar Multiline Lithotriptor, Extracorporeal Shock-Wave, Urological

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Lithostar Multiline

Trade Name

Lithostar

Generic Name

Lithotriptor, extracorporeal shock-wave, urological

PMA Number

P870018 ↗

FDA Product Code

LNS

Device Class

Class II

Regulation

21 CFR Part 876.5990

Advisory Committee

Gastroenterology, Urology

FDA Decision

APRL

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See all devices from Siemens Corp. →

• What types of stones can the Lithostar Multiline treat, and how does it work to break them down?

  The Lithostar Multiline is designed to non-invasively fragment kidney stones, ureteral stones, and gallstones using high-energy shock waves. These shock waves target and break down the calculi (stones) into smaller pieces, allowing them to either pass naturally or be more easily removed through subsequent medical procedures. This method avoids the need for surgical intervention.

• Is the Lithostar Multiline a single-use device or reusable, and what maintenance does it require?

  The Lithostar Multiline is a reusable medical instrument intended for use in clinical settings like urology and gastroenterology departments. To maintain optimal performance and ensure patient safety, it requires proper maintenance, calibration, and storage as outlined by the manufacturer’s guidelines. Regular upkeep is essential due to its complex design and repeated use in shock-wave therapy.

• What regulatory pathway does the Lithostar Multiline follow, and which medical specialties are primarily associated with its use?

  The Lithostar Multiline follows the FDA Premarket Approval (PMA) pathway, with PMA number P870018. It is primarily used in gastroenterology and urology departments, as indicated by its advisory committee designation (GU) and regulatory classification under 21 CFR 876.5990. This pathway ensures rigorous evaluation for devices intended for non-invasive stone fragmentation.

• How is the Lithostar Multiline supplied, and what clinical environments is it intended for?

  The Lithostar Multiline is supplied as a reusable medical instrument, meaning it is designed for repeated use in controlled clinical settings. It is specifically intended for use in urology and gastroenterology departments, where trained professionals can administer extracorporeal shock-wave lithotripsy under sterile conditions. Its reusable nature requires adherence to strict cleaning, sterilization, and maintenance protocols.