Ethos® ECD-100
Ethos® ECD-100 (CS-ECD-100) is a Class II device made by Cs Medical LLC, cleared under FDA 510(k) K230381 on 7 Jun 2023 and listed in FDA GUDID since 31 Jul 2023 (UDI-DI B205CSECD1001), 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 | NumberB205CSECD1001 | Date31 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230381 | Date7 Jun 2023 | StatusActive |
Official records
- FDA 510(k) database K230381
Across registries
- FDA 510(k) K230381 decided 7 Jun 2023 Active
- FDA GUDID UDI-DI B205CSECD1001 listed 31 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K230381
- Listed FDA GUDID B205CSECD1001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ethos®
- Generic name
- Ultrasound imaging transducer washer-disinfector (chemical)
- Model / Ref / Catalog
- ECD-100, CS-ECD-100
- Primary DI / UDI-DI
- B205CSECD1001
- 510(k) Number
- FDA product code
- PSW
- GMDN term
- Ultrasound imaging transducer washer-disinfector (chemical)
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid).
- GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor by Pci Medical, Inc.
- CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 by CS MEDICAL LLC
- CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant by CS MEDICAL LLC