Storz Modulith Lithotripter SLX Mobile

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

Full name

Storz Modulith Lithotripter, Model Slx for Fragmentation of Urinary and Upper Ureteral Calculi (Mobile Version)

Trade Name

Storz Modulith (Tm) Lithotripter

Generic Name

Lithotriptor, extracorporeal shock-wave, urological

PMA Number

P920051 ↗

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 Karl Storz Endoscopy-America, Inc. →

• What clinical specialties is the Storz Modulith Lithotripter SLX primarily used in, and how does its mobile design benefit these settings?

  The Storz Modulith Lithotripter SLX is designed for use in urology and gastroenterology procedures, as indicated by its advisory committee classification (GU) and medical specialty description. Its mobile configuration allows deployment in clinical environments where fixed lithotripter systems are impractical, such as smaller outpatient clinics, mobile surgical units, or facilities lacking dedicated lithotripsy rooms. This flexibility ensures access to extracorporeal shock-wave lithotripsy for patients with urinary or upper ureteral calculi without requiring permanent infrastructure.

• Is the Storz Modulith Lithotripter SLX intended for single-use or reusable applications, and what sterility considerations apply?

  The device itself is reusable, as explicitly stated in the description, but it requires sterile coupling components for direct patient contact. This means the core lithotripter unit remains non-sterile for operational use, while disposable or sterilized accessories (e.g., coupling pads or gel applicators) must be used to maintain patient safety and infection control during procedures.

• What regulatory pathway does the Storz Modulith Lithotripter SLX follow, and how does this affect its use in clinical settings?

  The device follows the FDA Pre-Market Approval (PMA) pathway, as indicated by the FDA_PMA authorization and PMA number (P920051). This pathway ensures rigorous evaluation of its safety and effectiveness for extracorporeal shock-wave lithotripsy of urinary and upper ureteral calculi, as classified under product code LNS and regulation 876.5990. Clinicians can rely on this approval for evidence-based use in treating kidney and ureter stones, though adherence to manufacturer guidelines and sterile protocols remains critical.

• Are there specific storage requirements for the Storz Modulith Lithotripter SLX to maintain its performance and functionality?

  The device’s storage conditions are manufacturer-specified, meaning Karl Storz Endoscopy-America, Inc. provides detailed instructions (likely in the user manual or technical documentation) to ensure optimal performance. While the data does not specify exact conditions (e.g., temperature, humidity), typical lithotripter systems require protection from physical damage, contamination, and environmental extremes. Always follow the manufacturer’s guidelines to preserve calibration, mechanical integrity, and operational reliability.