Econolith E3000 SW-6-A999b
Econolith E3000 SW-6-A999b is a Class II device made by Medispec, Ltd., cleared under FDA 510(k) K040461 on 25 May 2004 and listed in FDA GUDID since 8 Aug 2018 (UDI-DI 07290016498301), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016498301 | Date8 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040461 | Date25 May 2004 | StatusActive |
Official records
- AccessGUDID record 07290016498301
- FDA 510(k) database K040461
Across registries
- FDA 510(k) K040461 decided 25 May 2004 Active
- FDA GUDID UDI-DI 07290016498301 listed 8 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K040461
- Listed FDA GUDID 07290016498301
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Econolith E3000
- Generic name
- Electrohydraulic lithotripsy system
- Model / reference
- SW-6-A999b
- Primary DI / UDI-DI
- 07290016498301
- 510(k) Number
- FDA product code
- LNS
- GMDN term
- Electrohydraulic lithotripsy system
- Device class
- Class II
- Regulation number
- 876.5990
- GUDID distribution status
- In Commercial Distribution
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- INTEGRA by Direx Systems Corp.
- Break Wave Lithotriptor, Extracorporeal Shock-Wave, Urological by Sonomotion, Inc.