InnovaMatrix
510(k) K193552
InnovaMatrix is a device classified as Unclassified made by Triad Life Sciences, Inc., cleared under FDA 510(k) K193552 on 21 Oct 2020, 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 | NumberK193552 | Date21 Oct 2020 | StatusActive |
Official records
- FDA 510(k) database K193552
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KGN
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193552
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 | |||
|---|---|---|---|---|
| InnovaMatrix AC IMX-0202-01 | IMX-0202-01 / IMX-0202-01 | 00850002643152 | — | On the market |
| InnovaMatrix AC IMX-0203-01 | IMX-0203-01 | 00850002643428 | — | On the market |
| InnovaMatrix AC IMX-0304-01 | IMX-0304-01 | 00850002643435 | — | On the market |
| InnovaMatrix AC IMX-0404-01 | IMX-0404-01 / IMX-0404-01 | 00850002643169 | — | On the market |
| InnovaMatrix AC IMX-0406-01 | IMX-0406-01 / IMX-0406-01 | 00850002643183 | — | On the market |
| InnovaMatrix AC IMX-0505-01 | IMX-0505-01 / IMX-0505-01 | 00850002643176 | — | On the market |
| InnovaMatrix AC IMX-15MM-01 | IMX-15MM-01 / IMX-15MM-01 | 00850002643145 | — | On the market |
| InnovaMatrix AC IMX-18MM-01 | IMX-18MM-01 | 00850002643411 | — | On the market |
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