# K040518: Select Fabricators, Inc., Agmed Tex Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Select Fabricators, Inc.
- Decided: Oct 27, 2004 after 243 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 1.

## Most influential descendants
- K133137: Cisnap Closed Incision System (2014), 0 descendants of its own

## Indications for use
Local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I - IV dermal ulcers (vascular, venous, pressure, and diabetic).

Source page: https://510kreport.com/device/K040518
Methodology: https://510kreport.com/methodology