Olympus WA47778A
Olympus WA47778A is a stopcock (FDA Class II) made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K213207 on 22 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 27 Jan 2023 (UDI-DI 04042761085939), 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 | Number04042761085939 | Date27 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213207 | Date22 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 04042761085939
- FDA 510(k) database K213207
- FDA 510(k) database K200369
Across registries
- FDA 510(k) K213207 decided 22 Dec 2021 Active
- FDA GUDID UDI-DI 04042761085939 listed 27 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K200369
- Cleared FDA 510(k) K213207
- Listed FDA GUDID 04042761085939
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Olympus
- Generic name
- Stopcock
- Model / Ref / Catalog
- WA47778A
- Primary DI / UDI-DI
- 04042761085939
- FDA product code
- FGB, HIH
- GMDN term
- Stopcock
- Device class
- Class II
- Regulation number
- 876.1500, 884.1690
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Stopcock.