Colibrí
510(k) K232756
Colibrí is a Class II device made by Copan Wasp Srl, cleared under FDA 510(k) K232756 on 27 Dec 2023, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232756 | Date27 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K232756
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LON
- Device class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232756
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Colibrí™ Primary Tube with Saline WR090-01-0011 | WR090-01-0011 / WR090-01-0011 | 18052870817966 | — | On the market |
| Colibrí™ Primary Tube with Water WR090-01-0003 | WR090-01-0003 / WR090-01-0003 | 18050148217975 | — | On the market |
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