Richard Wolf Piezolith E.L.P. Lithotript MODEL2300

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

Generic Name

Lithotriptor, extracorporeal shock-wave, urological

PMA Number

P890013 ↗

FDA Product Code

LNS

Device Class

Class II

Regulation

21 CFR Part 876.5990

Advisory Committee

Gastroenterology, Urology

FDA Decision

APRL

• Suction and Irrigation Tubes

  Class II

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• Needle, Spray

  Class II

  FDA 510(k) K770710 Active Cleared 26 Apr 1977

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  Class II

  FDA 510(k) K003164 Active Cleared 8 Jan 2001

• Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories

  Class II

  FDA 510(k) K042523 Active Cleared 18 Mar 2005

• Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector

  Class II

  FDA 510(k) K972927 Active Cleared 6 Nov 1997

• Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

  Class II

  FDA 510(k) K051176 Active Cleared 5 Oct 2005

See all devices from Richard Wolf Medical Instruments Corp. →

• What clinical specialties is the Richard Wolf Piezolith E.L.P. Lithotript Model 2300 primarily used in, and why is this relevant for my practice?

  The Model 2300 is designed for use in urology and gastroenterology departments, as indicated by its advisory committee classification (GU) and OpenFDA specialty designation. This device is specifically intended for fragmenting urinary stones via extracorporeal shock-wave lithotripsy, making it most relevant for clinicians treating patients with kidney, ureteral, or bladder stones. Its application aligns with procedures in these specialties, ensuring compatibility with existing workflows for stone management.

• Is the Richard Wolf Piezolith E.L.P. Lithotript Model 2300 a single-use or reusable device, and what maintenance does it require?

  The Model 2300 is a reusable medical device, as explicitly stated in the description. Since it is not disposable, it requires regular maintenance and calibration to ensure consistent performance and safety. Proper cleaning, servicing, and adherence to manufacturer guidelines are essential to uphold its functionality over repeated use in clinical settings.

• How is the regulatory approval status of this device relevant for purchasing or clinical use?

  The Richard Wolf Piezolith E.L.P. Lithotript Model 2300 is authorized under the FDA’s Premarket Approval (PMA) process with approval number P890013 and governed by regulation 876.5990. This means it has undergone rigorous review to demonstrate safety and effectiveness for its intended use—fragmenting urinary stones via extracorporeal shock-wave lithotripsy. For purchasers or clinicians, this approval confirms the device meets FDA’s Class II standards, ensuring compliance with regulatory requirements for its clinical application.

• What storage and handling precautions should be taken for the Richard Wolf Piezolith E.L.P. Lithotript Model 2300?

  While the device itself is reusable, the description emphasizes that storage and handling must comply with manufacturer guidelines to preserve its functionality. Since it is not sterile (as it is reusable and not described as disposable), proper cleaning, maintenance, and environmental controls (e.g., temperature, humidity) are critical. Follow Richard Wolf’s instructions to avoid contamination or damage, ensuring the device remains operational for repeated clinical use.