Identifiers
- 510(k) Number
- K170122 FDA 510(k)
- FDA Product Code
- LNS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5990 FDA 510(k)
- Regulation Number
- 876.5990 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an extracorporeal shock-wave lithotriptor, a type of medical device used to break down kidney stones using focused shock waves. It is classified as a Class II medical device under FDA regulation.
It is supplied as a reusable system and has received FDA 510(k) clearance (K170122) as substantially equivalent to a predicate device. The device is used in urology and gastroenterology settings for the non-invasive treatment of urinary tract stones.
Frequently asked questions
What is the Delta III Lithotripter used for?
The Delta III Lithotripter is used for the non-invasive treatment of urinary tract stones by breaking down kidney stones using focused shock waves, and it is used in urology and gastroenterology settings.
Is the Delta III Lithotripter reusable or single-use?
The Delta III Lithotripter is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between procedures.
What regulatory clearance does the Delta III Lithotripter have?
The Delta III Lithotripter has received FDA 510(k) clearance under submission K170122, determined to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Delta® III — Dornier MedTech Americas, Delta III ® Pro — Dornier MedTech Americas, Dornier MedTech - Delta III Pro, FDA Clearance for Delta III Lithotripter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170122 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
- FDA Applicant
- Dornier Medtech America
Sources (1)
- FDA 510(k) K170122 24 fields · synced Oct 6, 2026