Sonolith 2000
PMA P880011
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP880011 | Date23 Jun 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Technomed International Sonolith 2000
- Generic Name
- Lithotriptor, extracorporeal shock-wave, urological
- PMA Number
- FDA Product Code
- LNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5990
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Sonolith 2000 is an extracorporeal shock-wave lithotriptor, a Class II medical device designed for the non-invasive fragmentation of urinary stones (urolithiasis) and gallstones (cholelithiasis) using high-energy shock waves. It operates by directing focused acoustic pulses to break down calcified deposits in the urinary tract or biliary system without surgical intervention, facilitating their subsequent passage or removal.
This device is supplied as a reusable, hospital-based system intended for use in urology and gastroenterology settings. It requires specialized training for operation and is regulated under FDA Premarket Approval (PMA P880011) and the applicable Code of Federal Regulations (21 CFR 876.5990). Sterility and maintenance protocols must adhere to manufacturer guidelines, and its use is restricted to licensed medical professionals in controlled clinical environments.
Other devices from Edap International Corp.
Questions
AI-generated answers, 18 Sep 2026
What types of stones can the Sonolith 2000 treat, and how does it work to break them down?
The Sonolith 2000 is designed to non-invasively fragment urinary stones (urolithiasis) in the urinary tract and gallstones (cholelithiasis) in the biliary system. It achieves this by generating high-energy shock waves that are precisely directed at the stones, causing them to break into smaller pieces that can then be passed naturally or removed more easily without surgery.
Is the Sonolith 2000 intended for use in outpatient clinics, or is it primarily a hospital-based system?
The Sonolith 2000 is supplied as a reusable, hospital-based system, meaning it is intended for use in controlled clinical environments like urology and gastroenterology departments within hospitals. Its design and regulatory requirements reflect its need for specialized training and infrastructure typically found in hospital settings.
How is the device maintained, and what sterility precautions should be taken when using it?
Since the Sonolith 2000 is a reusable system, it requires adherence to strict manufacturer guidelines for maintenance and sterility protocols. Proper cleaning, disinfection, and storage procedures must be followed to ensure safe and effective use, as outlined in the manufacturer’s instructions to prevent contamination or damage to the device.
What training or qualifications are needed to operate the Sonolith 2000?
The Sonolith 2000 requires specialized training for operation due to its complexity and the precision needed to safely deliver shock waves. Only licensed medical professionals with proper training should use the device, as its application involves clinical judgment and technical expertise in urology or gastroenterology.
What regulatory pathway does the Sonolith 2000 follow, and how does that affect its use?
The Sonolith 2000 is regulated under the FDA Premarket Approval (PMA) pathway, specifically under PMA number P880011. This means its use is governed by strict compliance with FDA guidelines and manufacturer instructions, ensuring it meets safety and effectiveness standards for non-invasive stone fragmentation in controlled clinical environments.