Olympus A0223
Olympus A0223 is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K984417 on 24 Feb 1999 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 14042761001042), 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 | Number14042761001042 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK984417 | Date24 Feb 1999 | StatusActive |
Official records
- AccessGUDID record 14042761001042
- FDA 510(k) database K984417
Across registries
- FDA 510(k) K984417 decided 24 Feb 1999 Active
- FDA GUDID UDI-DI 14042761001042 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K984417
- Listed FDA GUDID 14042761001042
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Olympus
- Generic name
- Endoscope working-channel valve, single-use
- Model / Ref / Catalog
- A0223
- Primary DI / UDI-DI
- 14042761001042
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Endoscope working-channel valve, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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