# K973170: Sis Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Apr 30, 1998 after 248 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
No predicates in its family tree.
237 later devices descend from it; 3 cite it directly.
0 of 238 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 no predicate by number.

## Most influential descendants
- K993948: Sis Wound Dressing II (2000), 235 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant (1998), 92 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own

## Indications for use
The SIS Wound Dressing is intended for temporary coverage of partial-thickness skin loss injury, such as burns, abrasions, decubitus and chronic vascular ulcers, and autograft donor sites. This device is intended for one-time use.

Source page: https://510kreport.com/device/K973170
Methodology: https://510kreport.com/methodology