# K143078: Bookwalter Gordon Adjustable Compression Element

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Surgical
- Decided: May 14, 2015 after 199 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040615 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040615: Compressar Supercomfort Disc and Strongarm Supercomfort System, Advanced Vascular Dynamics (2004) Summary page 6.

## Indications for use
The Bookwalter Gordon Adjustable Compression Element is indicated for use to provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.

Source page: https://510kreport.com/device/K143078
Methodology: https://510kreport.com/methodology