Acticoat Flex 7 Dressing
510(k) K083113
Acticoat Flex 7 Dressing is a device classified as Unclassified made by Smith & Nephew, Inc., cleared under FDA 510(k) K083113 on 22 Jul 2009, 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 | NumberK083113 | Date22 Jul 2009 | StatusActive |
Official records
- FDA 510(k) database K083113
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- Withdrawn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 K083113
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 | |||
|---|---|---|---|---|
| ACTICOAT Flex 66027683 | 66027683 / 66027683 | 05000223503727 | Width 1 in; Length 24 in | On the market |
| ACTICOAT FLEX 66027684 | 66027684 / 66027684 | 05000223502218 | Length 2 in; Width 2 in | On the market |
| ACTICOAT Flex 66027685 | 66027685 / 66027685 | 05000223502249 | Width 4 in; Length 5 in | On the market |
| ACTICOAT Flex 66027686 | 66027686 / 66027686 | 05000223502270 | Width 6 in; Length 6 in | On the market |
| ACTICOAT Flex 66027687 | 66027687 / 66027687 | 05000223502300 | Width 8 in; Length 16 in | On the market |
| ACTICOAT Flex 66027688 | 66027688 / 66027688 | 05000223502331 | Length 16 in; Width 16 in | On the market |
| ACTICOAT Flex 66027689 | 66027689 / 66027689 | 05000223503284 | Length 4 in; Width 4 in | On the market |
| ACTICOAT Flex 66027691 | 66027691 / 66027691 | 05000223503697 | Length 48 in; Width 4 in | On the market |
| ACTICOAT FLEX3 16" X 16" 66800433 | 66800433 / 66800433 | 00040565124896 | — | On the market |
| ACTICOAT FLEX3 2" X 2" 66800402 | 66800402 / 66800402 | 00040565124797 | — | On the market |
| ACTICOAT FLEX3 4" X 4" 66800406 | 66800406 / 66800406 | 00040565124810 | — | On the market |
| ACTICOAT FLEX3 4" X 48" 66800434 | 66800434 / 66800434 | 00040565124919 | — | On the market |
| ACTICOAT FLEX3 4" X 8" 66800417 | 66800417 / 66800417 | 00040565124858 | — | On the market |
| ACTICOAT FLEX3 8" X 16" 66800418 | 66800418 / 66800418 | 00040565124872 | — | On the market |
| ACTICOAT FLEX7 16" X 16" 66800408 | 66800408 / 66800408 | 00040565124414 | — | On the market |
| ACTICOAT FLEX7 2" x 2" 66800403 | 66800403 / 66800403 | 00040565124292 | — | On the market |
| ACTICOAT FLEX7 2.5CMX60CM CTN OF 5 66800545 | 66800545, 66800544 / 66800545 | 00040565125275 | — | On the market |
| ACTICOAT FLEX7 4" X 5" 66800405 | 66800405 / 66800405 | 00040565124339 | — | On the market |
| ACTICOAT FLEX7 6" X 6" 66800427 | 66800427 / 66800427 | 00040565124582 | — | On the market |
| ACTICOAT FLEX7 8" X 16" 66800407 | 66800407 / 66800407 | 00040565124391 | — | On the market |
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