Dornier MedTech Delta III
by Dornier MedTech GmbH 2 variants
Dornier MedTech Delta III (K1039062) is a Class II device made by Dornier MedTech GmbH, cleared under FDA 510(k) K172084 on 8 Aug 2017 and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 04049957005429), 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 | Number04049957005429 | Date13 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172084 | Date8 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 04049957005429
- FDA 510(k) database K172084
Across registries
- FDA 510(k) K172084 decided 8 Aug 2017 Active
- FDA GUDID UDI-DI 04049957005429 listed 13 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K172084
- Listed FDA GUDID 04049957005429
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dornier MedTech
- Generic name
- Electromechanical lithotripsy system, extracorporeal
- Model / Ref / Catalog
- Delta III, K1039062
- Primary DI / UDI-DI
- 04049957005429
- 510(k) Number
- FDA product code
- LNS
- GMDN term
- Electromechanical lithotripsy system, extracorporeal
- Device class
- Class II
- Regulation number
- 876.5990
- GUDID distribution status
- In Commercial Distribution
Similar devices
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- Modulith SLX-F2 by Karl Storz Endoscopy-America, Inc.
- EDAP LT.02 Shock Wave Lithotripter by Edap International Corp.
- Delta III Lithotripter by Dornier MedTech America, Inc.
- LITHODIAMOND ULTRA by Pck Electronic Industry and Trade Co, Ltd.
- LM-9300 Plus Lithotripter by Lite-Med, Inc.
- Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter by Genemed, Inc.