Olympus A2891
Olympus A2891 is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K992141 on 29 Sep 1999 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04042761004442), 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 | Number04042761004442 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992141 | Date29 Sep 1999 | StatusActive |
Official records
- AccessGUDID record 04042761004442
- FDA 510(k) database K992141
Across registries
- FDA 510(k) K992141 decided 29 Sep 1999 Active
- FDA GUDID UDI-DI 04042761004442 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K992141
- Listed FDA GUDID 04042761004442
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Olympus
- Generic name
- General-purpose endoscopic needle, reusable
- Model / Ref / Catalog
- A2891
- Primary DI / UDI-DI
- 04042761004442
- 510(k) Number
- FDA product code
- FDC
- GMDN term
- General-purpose endoscopic needle, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under General-purpose endoscopic needle, reusable.