# K052229: Coloplast Ostomy Rod, Model 12814

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Oct 13, 2006 after 423 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 K811240 (1981). 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)
- K811240: Sur-Fit Loop Ostomy O.R. Set, E. R. Squibb & Sons, Inc. (1981) Summary page 2.

## Indications for use
Coloplast Ostomy Rod is for use in loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy) ostomy surgery.

Source page: https://510kreport.com/device/K052229
Methodology: https://510kreport.com/methodology