Econolith Extracorporeal Shock-Wave Lithotriptor
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- ECONOLITH(TM) LITHOTRIPTER FDA PMA
- Generic Name
- Lithotriptor, extracorporeal shock-wave, urological FDA PMA
Identifiers
- PMA Number
- P950043 FDA PMA
- FDA Product Code
- LNS FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 876.5990 FDA PMA
- Regulation Number
- 876.5990 FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APRL FDA PMA
The Econolith Extracorporeal Shock-Wave Lithotriptor is an extracorporeal shock-wave lithotriptor designed for urological applications. It is classified as a Class II medical device and is intended for the non-invasive fragmentation of upper urinary tract stones measuring between 5 and 20 millimeters in size.
This device is used in clinical settings under regulatory approval, specifically authorized by the FDA under PMA number P950043. Supplied as a reusable medical instrument, it operates within the scope of urology and gastroenterology advisory committees. Storage and handling must comply with regulatory standards for extracorporeal lithotripsy equipment, ensuring proper maintenance and sterility protocols are followed.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P950043 | Class II | Active |
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Manufacturer
- Manufacturer
- Medispec, Ltd.
Sources (1)
- FDA PMA P950043 24 fields · synced Sep 18, 2026