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Duckworth & Kent, Ltd., Implantation System, Model Dk7786
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K081382
Identifiers
- 510(k) Number
- K081382 FDA 510(k)
- FDA Product Code
- KYB FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4300 FDA 510(k)
- Regulation Number
- 886.4300 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Duckworth & Kent, Ltd., Implantation System, Model Dk7786 by Duckworth & Kent Ltd. — Class I — MDD, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K081382 | Class I | Active |
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Manufacturer
- Manufacturer
- Duckworth & Kent Ltd.
- FDA Applicant
- Duckworth & Kent, Ltd.
Sources (2)
- FDA 510(k) K081382 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026