# K180634: Surgical Silver Post Operative Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions, Ltd.
- Decided: Aug 7, 2018 after 148 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914604 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091034: Aquacel AG Surgical, Convatec (2009) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.

Source page: https://510kreport.com/device/K180634
Methodology: https://510kreport.com/methodology