Iodoflex
by Smith & Nephew Medical, Ltd.
510(k) K190756
Iodoflex is a device classified as Unclassified made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K190756 on 20 Dec 2019, 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 | NumberK190756 | Date20 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K190756
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRO
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190756
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 | |||
|---|---|---|---|---|
| Iodoflex Dressing 3x10g USA 6602134010 | 6602134010 / 6602134010 | 00040565122526 | — | On the market |
| Iodoflex Dressing 5x5g USA 6602133005 | 6602133005 / 6602133005 | 00040565122502 | — | On the market |
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