# K032589: Enclose II Anastomosis Assist Device

- Pathway: 510(k) (Special)
- Applicant: Novare Surgical Systems, Inc.
- Decided: Sep 5, 2003 after 14 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: 2 generations back to K010694 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010694: Includer Clamp, Novare Surgical Systems, Inc. (2002) Summary page 1.
- K023682: Enclose Anastomosis Assist Device, Novare Surgical Systems, Inc. (2003)

## Indications for use
The ENcloseTMII Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.

Source page: https://510kreport.com/device/K032589
Methodology: https://510kreport.com/methodology