Delphi System DP2001
Delphi System DP2001 is a Class II device made by Cs Medical LLC, cleared under FDA 510(k) K242907 on 6 Jun 2025 and listed in FDA GUDID since 30 Jun 2025 (UDI-DI 08800270913091), 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 | Number08800270913091 | Date30 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242907 | Date6 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 08800270913091
- FDA 510(k) database K242907
Across registries
- FDA 510(k) K242907 decided 6 Jun 2025 Active
- FDA GUDID UDI-DI 08800270913091 listed 30 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K242907
- Listed FDA GUDID 08800270913091
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Delphi System
- Generic name
- Electrosurgical system generator
- Model / reference
- DP2001
- Primary DI / UDI-DI
- 08800270913091
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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