# K023682: Enclose Anastomosis Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Novare Surgical Systems, Inc.
- Decided: Jan 16, 2003 after 76 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 K010694 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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)

## Most influential descendants
- K032589: Enclose II Anastomosis Assist Device (2003), 0 descendants of its own

## Indications for use
The ENcloseTMAnastomosis 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 anastomoses in ascending aortas free of atheromatous disease.

Source page: https://510kreport.com/device/K023682
Methodology: https://510kreport.com/methodology