# K983753: Star Temporary Wound Cover

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics, Inc.
- Decided: Nov 18, 1999 after 398 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022011: V.a.C. Abdominal Dressing (2003), 17 descendants of its own
- K100787: Renasys F/-AB Abdominal Wound Dressing Kit (2010), 11 descendants of its own
- K112784: Renasys AB Abominal Dressing Kit (2011), 10 descendants of its own
- K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (2015), 5 descendants of its own
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own

## Indications for use
For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.

Source page: https://510kreport.com/device/K983753
Methodology: https://510kreport.com/methodology