# K993948: Sis Wound Dressing II

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Jan 6, 2000 after 45 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 2 generations back to K881854 (1988). 7 ancestors in all.
235 later devices descend from it; 10 cite it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973170: Sis Wound Dressing, Cook Biotech, Inc. (1998) Summary page 1.
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K913023: Skintemp, Biocore (1991) Summary page 1.
- K910944: Medifil, Biocore (1991) Summary page 1.

## Most influential descendants
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own
- K021792: Bilayer Matrix Wound Dressing (2002), 53 descendants of its own

## Indications for use
The SIS Wound Dressing Il is intended for the management of wounds including: Partial and full-thickness wounds Pressure ulcers Venous ulcers Diabetic ulcers Chronic vascular ulcers Tunneled/undermined wounds Surgical wounds (donor sites/grafts, post-moh’s surgery, post-laser surgery, podiatric, wound dehiscence) Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) Draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K993948
Methodology: https://510kreport.com/methodology