# K974251: X-Cell Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Jun 22, 1998 after 221 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NU-GEL hydrogel wound dressing: named in the summary without a submission number
- (no number) Aquacel wound dressing: named in the summary without a submission number

## Most influential descendants
- K023237: Xylos Surgical Mesh (2003), 12 descendants of its own
- K081882: Modification to Xylos Surgical Mesh (2008), 11 descendants of its own
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own
- K024054: Xylos Xcell Antimicrobial Dressing (2003), 7 descendants of its own
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own

## Indications for use
X-Cell™ wound dressing may be used for the management of: Partial to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); First und Second degree bums (severe sunbum, eic.); Post-operative surgical wounds; Donor sites; Dermal Lesions (cuts, abrasions, exc,)

Source page: https://510kreport.com/device/K974251
Methodology: https://510kreport.com/methodology