Break Wave Lithotriptor, Extracorporeal Shock-Wave, Urological
by Sonomotion, Inc. 2 variants
510(k) K261086
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261086 | Date29 Apr 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Break Wave
- 510(k) Number
- FDA Product Code
- LNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5990
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Break Wave Lithotriptor is an extracorporeal shock-wave device designed for urological lithotripsy. It employs focused shock waves to fragment kidney or ureteral stones non-invasively, enabling safe and effective treatment without anesthesia. Classified as a Class II medical device, it is intended for use in urological procedures to manage stone disease through mechanical fragmentation.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including hospitals and outpatient facilities. It operates under FDA 510(k) clearance (K261086) and adheres to regulatory standards for extracorporeal lithotripsy. The system requires proper calibration, maintenance, and adherence to manufacturer guidelines to ensure safe and effective performance. No specific sterility claims are stated in the data.
Other devices from Sonomotion, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Break Wave Lithotriptor used for?
The Break Wave Lithotriptor is an extracorporeal shock-wave device specifically designed for urological lithotripsy. It employs focused shock waves to mechanically fragment kidney or ureteral stones, enabling non-invasive treatment of stone disease without the need for anesthesia. This approach helps avoid surgical intervention while ensuring effective stone management in clinical settings.
Is the Break Wave Lithotriptor reusable or single-use?
The Break Wave Lithotriptor is supplied as a reusable medical instrument. It is intended for use in clinical environments like hospitals and outpatient facilities, where proper calibration, maintenance, and adherence to manufacturer guidelines are essential to ensure safe and effective performance over multiple procedures.
Does the Break Wave Lithotriptor require sterilization?
The device data does not specify any claims regarding sterility for the Break Wave Lithotriptor. As a reusable instrument, it must be cleaned, maintained, and handled according to established clinical protocols to prevent contamination and ensure patient safety. Always follow the manufacturer’s instructions for reprocessing.
What regulatory pathway does the Break Wave Lithotriptor follow?
The Break Wave Lithotriptor is cleared under the FDA’s 510(k) pathway, with clearance number K261086. It is classified as a Class II medical device and is intended for use in urological procedures to manage stone disease. The device adheres to regulatory standards for extracorporeal lithotripsy and requires compliance with manufacturer guidelines for safe operation.
Where can the Break Wave Lithotriptor be used?
This device is intended for use in clinical settings, including hospitals and outpatient facilities equipped to handle extracorporeal shock-wave therapy. Its design supports reusable applications, making it suitable for environments where multiple patients may require treatment. Proper training and facility setup are necessary to ensure effective and safe operation.