# K152544: Agem Ag Mesh Dressing with Silver

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yuanxing Nano-Pharma Co., Ltd.
- Decided: May 23, 2016 after 262 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: 3 generations back to K914579 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053256: 3M Tegaderm Silver (AG) Mesh, 3M Company (2005) Summary page 5.

## Indications for use
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over: • abrasions • ulcers • trauma wounds • surgical wounds • first and second degree burns • donor sites This product is not designed, sold or intended for use except as indicated.

Source page: https://510kreport.com/device/K152544
Methodology: https://510kreport.com/methodology