Olympus A22261A
Olympus A22261A is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K904939 on 7 Jan 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761021661), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04042761021661 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904939 | Date7 Jan 1992 | StatusActive |
Official records
- AccessGUDID record 04042761021661
- FDA 510(k) database K904939
Across registries
- FDA 510(k) K904939 decided 7 Jan 1992 Active
- FDA GUDID UDI-DI 04042761021661 listed 21 Sep 2016 Listed
Recalls
-
- Terminated Z-3102-2011
The device sterile package seal shows evidence of being breached or was breached
Timeline
- Cleared FDA 510(k) K904939
- Recall initiated FDA recalls Z-3102-2011
- Listed FDA GUDID 04042761021661
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Olympus
- Generic name
- Endometrial biopsy curette
- Model / Ref / Catalog
- A22261A
- Primary DI / UDI-DI
- 04042761021661
- FDA product code
- EZO
- GMDN term
- Endometrial biopsy curette
- Device class
- Class II
- Regulation number
- 876.4770
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Endometrial biopsy curette.