# K071775: DASH

- Pathway: 510(k) (Traditional)
- Applicant: Ezsurgical
- Decided: Aug 7, 2007 after 39 days
- Product code: GAD (Retractor)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The DASHTM is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.

Source page: https://510kreport.com/device/K071775
Methodology: https://510kreport.com/methodology