Healthtronics Lithotron Lithotripsy System
by Healthtronics Surgical Services, Inc.
PMA P970019
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970019 | Date21 Jul 1997 | 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- Withdrawn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
- Healthtronics Lithotron Lihtotripsy System
- 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 Lithotron Lithotripsy System is an extracorporeal shock-wave lithotriptor, classified under urological devices. It is designed to fragment renal and upper ureteral calculi (stones) measuring between 4 mm and 20 mm in size using high-energy shock waves generated externally to the body. This non-invasive procedure aims to facilitate the passage of stone fragments through the urinary tract, reducing the need for surgical intervention.
This system is intended for use in clinical settings such as urology and gastroenterology departments, where trained operators apply it under controlled conditions. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure safety and efficacy. The device is regulated under FDA_PMA approval (PMA Number: P970019) and adheres to regulatory standards outlined in 21 CFR 876.5990, ensuring compliance with shock-wave lithotripsy protocols for urological applications.
Other devices from Healthtronics Surgical Services, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of urinary stones can the Lithotron Lithotripsy System treat, and what size range is it designed for?
The Lithotron Lithotripsy System is specifically designed to treat renal (kidney) and upper ureteral stones, known as calculi. It is approved for stones measuring between 4 millimeters and 20 millimeters in diameter. The device uses high-energy shock waves to fragment these stones into smaller pieces, which can then pass more easily through the urinary tract.
Is the Lithotron Lithotripsy System reusable, and what maintenance does it require?
Yes, the Lithotron Lithotripsy System is supplied as a reusable medical device. Since it is intended for clinical use in urology and gastroenterology departments, it requires proper maintenance and calibration to ensure safety and consistent performance. Regular upkeep is necessary to comply with regulatory standards and maintain its efficacy for shock-wave lithotripsy procedures.
What regulatory approval does the Lithotron Lithotripsy System hold, and how does it ensure compliance?
The Lithotron Lithotripsy System holds FDA Pre-Market Approval (PMA) under PMA Number P970019. It adheres to regulatory standards outlined in 21 CFR 876.5990, which governs extracorporeal shock-wave lithotriptors for urological applications. This approval ensures the device meets safety and effectiveness requirements for treating renal and upper ureteral calculi between 4 mm and 20 mm.
In what clinical settings is the Lithotron Lithotripsy System intended for use?
The Lithotron Lithotripsy System is intended for use in clinical settings such as urology and gastroenterology departments. It is designed for trained operators to perform non-invasive shock-wave lithotripsy under controlled conditions, facilitating the fragmentation of stones in the urinary tract without surgical intervention.
How does the Lithotron Lithotripsy System differ from surgical stone removal procedures?
The Lithotron Lithotripsy System is a non-invasive procedure that uses externally generated high-energy shock waves to break down renal and upper ureteral stones into smaller fragments. Unlike surgical interventions, which involve direct access to the stone via incisions or endoscopes, this system avoids physical entry into the body, reducing risks such as infection or trauma while still enabling the stone fragments to pass naturally through the urinary tract.