510(k) · Cleared
ClearedEasy Loop, Model Ezl-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tools For Surgery, LLC · EZP Rod, Colostomy
Cleared on Mar 24, 2004 as substantially equivalent to K830945 (Convatec, A Division of E.R. Squibb & Sons, 1983) after a 64-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Mar 24, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- EZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830945 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK830945 Sur-Fit FlexibleConvatec, A Division of E.R. Squibb & Sons · 1983
- This deviceK040110 Easy Loop, Model Ezl-01Tools For Surgery, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830945 | Sur-Fit Flexible | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| 0 (this device) | K040110 | Easy Loop, Model Ezl-01 | Tools For Surgery, LLC | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K830945 | Sur-Fit FlexibleSummary page 1…alency is claimed against the following device: "Loop Ostomy Rod" manufactured by Convatec, a division of Bristol-Myers Squibb Co. of Skillman, NJ; 510O(K) 11K830945. 11. Description of the Device: The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing,… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All EZP devicesEZP Rod, Colostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZP
FDA has decided no EZP device since 2007.
Median 510(k) review, days · EZP
Too few EZP 510(k)s in any year since 2007 to give a median.
Recalls per year · EZP
No recall names EZP since 2007.
Adverse event reports per year · EZP
9in 2022
MAUDE reports naming product code EZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040110 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040110: Easy Loop, Model Ezl-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040110
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026