# K040110: Easy Loop, Model Ezl-01

- Pathway: 510(k) (Traditional)
- Applicant: Tools For Surgery, LLC
- Decided: Mar 24, 2004 after 64 days
- Product code: EZP (Rod, Colostomy)
- Device class: 2
- Regulation: 21 CFR 876.4270
- 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 K830945 (1983). 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)
- K830945: Sur-Fit Flexible, Convatec, A Division of E.R. Squibb & Sons (1983) Summary page 1.

## Indications for use
The Easy Loop is indicated for use in abdominal surgical procedures generally referred to as loop ostomies, or more specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained outside the body. This device, which prevents the exteriori[zed loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.

Source page: https://510kreport.com/device/K040110
Methodology: https://510kreport.com/methodology