DirectInject
by Stryker
510(k) K143661
DirectInject is a Class II device made by Stryker, cleared under FDA 510(k) K143661 on 2 Sep 2015, active as of 22 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 | FDA 510(k)SESE | NumberK143661 | Date2 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K143661
Recalls
-
- Terminated Z-1436-2021
Inability for the user to inject the paste from the syringe into the target location.
Timeline
- Cleared FDA 510(k) K143661
- Recall initiated FDA recalls Z-1436-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXP
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5300
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K143661
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 | |||
|---|---|---|---|---|
| Direct Inject 79-45903 | 79-45903 / 79-45903 | 07613327123371 | — | On the market |
| Direct Inject 79-45905 | 79-45905 / 79-45905 | 07613327123265 | — | On the market |
| Direct Inject 79-45910 | 79-45910 / 79-45910 | 07613327123272 | — | On the market |
| DirectInject 79-45143 | 79-45143 / 79-45143 | 07613327425468 | Length 5.0 cm | On the market |
| DirectInject 79-45144 | 79-45144 / 79-45144 | 07613327425475 | Length 5.0 cm | On the market |
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