Actisorb Silver 220 Antimicrobial Binding Dressing
FDA 510(k) K022483 · Johnson & Johnson Medical, Ltd.
510(k) numberK022483
Submission
- Device name
- Actisorb Silver 220 Antimicrobial Binding Dressing
- Applicant
- Johnson & Johnson Medical, Ltd.
Somerville, NJ, US - Received
- July 29, 2002
- Decision date
- February 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
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| K033523 | Collagen-Orc Antimicrobial MatrixFRO · Traditional | 10/21/2004SE |
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| K001690 | Protectiv Safety Blood Collection NeedleFMI · Traditional | 07/31/2000SE |
| K982641 | Advanced Nibp ModuleDXN · Traditional | 03/29/1999SE |
| K983362 | Nu-Gel * Wound DressingMGQ · Traditional | 12/16/1998SE |
| K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateKGN · Traditional | 08/20/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K980493 | I.V. Catheter SystemFOZ · Traditional | 04/28/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | 02/17/1998SE |
| K973699 | Ultralon Powder Free Latex Surgical GloveKGO · Traditional | 12/16/1997SE |
Questions and answers
When was Actisorb Silver 220 Antimicrobial Binding Dressing cleared by the FDA?
Actisorb Silver 220 Antimicrobial Binding Dressing (K022483) received a 510(k) decision of Substantially Equivalent on February 3, 2003, 189 days after the submission was received.
What is the product code of K022483?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.