Instrument Case
510(k) K231604
Instrument Case is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K231604 on 24 Aug 2023, active as of 22 Oct 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 | NumberK231604 | Date24 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K231604
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCT
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231604
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 | |||
|---|---|---|---|---|
| Instrument Case P1340904 | P1340904 / P1340904 | 09321502043953 | — | On the market |
Similar devices
Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).
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