Genestone 190 Lithotripter
by Bmt, Inc. PMA
Active
PMA P970062
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970062 | Date24 Jun 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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 Genestone 190 Lithotripter is an extracorporeal shock-wave lithotripter, a Class II medical device designed for the non-invasive fragmentation of urinary stones. It employs focused shock waves to break down kidney (renal pelvic and renal calyceal) and upper ureteral stones measuring between 5 and 20 millimeters in diameter, facilitating their subsequent passage or removal.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as urology and gastroenterology departments. It operates under FDA_PMA approval (P970062) and adheres to regulatory standards outlined in 21 CFR 876.5990, ensuring compliance with shock-wave lithotripsy protocols. Storage and maintenance instructions are manufacturer-specific, though no additional sterility or MRI safety data are provided in the specifications.
Questions
AI-generated answers, 18 Sep 2026
What types of urinary stones can the Genestone 190 Lithotripter treat, and what size range is it designed for?
The Genestone 190 Lithotripter is specifically designed for the non-invasive fragmentation of kidney stones located in the renal pelvis or renal calyces, as well as stones in the upper ureter. It is approved for stones measuring between 5 and 20 millimeters in diameter, helping to break them down so they can pass more easily or be removed.
Is the Genestone 190 Lithotripter intended for single-use or reusable applications in a clinical setting?
The Genestone 190 Lithotripter is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments like urology and gastroenterology departments. Maintenance and storage instructions are provided by the manufacturer, though specific details about cleaning or reprocessing protocols are not included in the available data.
What regulatory approval does the Genestone 190 Lithotripter hold, and how does it relate to its intended use?
The Genestone 190 Lithotripter holds FDA Premarket Approval (PMA) under the number P970062, which authorizes its use for the non-invasive fragmentation of urinary stones as described. This approval aligns with the device’s classification under 21 CFR 876.5990, ensuring compliance with shock-wave lithotripsy protocols for the specified stone sizes and anatomical locations.
Are there any special considerations for storage or handling of the Genestone 190 Lithotripter?
The Genestone 190 Lithotripter is a reusable device, so proper storage and maintenance are critical to ensure its functionality and safety. While manufacturer-specific instructions apply, the data does not provide explicit details about sterility or MRI safety. Clinicians should follow the manufacturer’s guidelines for cleaning, maintenance, and storage to maintain optimal performance.