Silver High Performance Dressing
by Advanced Medical Solutions Ltd
510(k) K183645
Silver High Performance Dressing is a device classified as Unclassified made by Advanced Medical Solutions Ltd, cleared under FDA 510(k) K183645 on 29 May 2019, active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183645 | Date29 May 2019 | StatusActive |
Official records
- FDA 510(k) database K183645
Recalls
-
- Ongoing Z-1806-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Timeline
- Cleared FDA 510(k) K183645
- Recall initiated FDA recalls Z-1806-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRO
- FDA applicant
- Advanced Medical Solutions, Ltd.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K183645
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 | |||
|---|---|---|---|---|
| ActivHeal | 9025070 / Silver Antimicrobial High Performance Dressing | 15032749025077 | — | On the market |
| ActivHeal | 9025087 / Silver Antimicrobial High Performance Dressing | 15032749025084 | — | On the market |
| ActivHeal | 9025094 / Silver Antimicrobial High Performance Dressing | 15032749025091 | — | On the market |
| ActivHeal | 9025100 / Silver Antimicrobial High Performance Dressing | 15032749025107 | — | On the market |
| ActivHeal | 9025117 / Silver Antimicrobial High Performance Dressing | 15032749025114 | — | On the market |
| ActivHeal | 9025124 / Silver Antimicrobial High Performance Dressing | 15032749025121 | — | On the market |
| ActivHeal | 9025506 / Silver Antimicrobial High Performance Dressing | 15032749025503 | — | On the market |
| GEMCORE360 | AM-WC-HPDAG12R / Silver Antimicrobial High Performance Dressing Rope | 10610888002156 | — | No longer on the market |
| GEMCORE360 | AM-WC-HPDAG22 / Silver Antimicrobial High Performance Dressing | 10610888002132 | — | No longer on the market |
| GEMCORE360 | AM-WC-HPDAG4475 / Silver Antimicrobial High Performance Dressing | 10610888002149 | — | No longer on the market |
| McKesson 177180 | 177180 | 10612479253138 | — | On the market |
| McKesson 177180 | 177180 | 00612479253131 | — | On the market |
| McKesson 177200 | 177200 | 10612479253015 | — | On the market |
| McKesson 177200 | 177200 | 00612479253018 | — | On the market |
| McKesson 177400 | 177400 | 00612479253049 | — | On the market |
| McKesson 177400 | 177400 | 10612479253046 | — | On the market |
| McKesson 177600 | 177600 | 10612479253077 | — | On the market |
| McKesson 177600 | 177600 | 00612479253070 | — | On the market |
| McKesson 177812 | 177812 | 00612479253100 | — | On the market |
| McKesson 177812 | 177812 | 10612479253107 | — | On the market |
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