# K071057: Colonic & Enema Nozzle

- Pathway: 510(k) (Traditional)
- Applicant: Tiller Mind Body, Inc.
- Decided: Oct 5, 2007 after 172 days
- Product code: KPL (Colonic Irrigation System)
- Device class: 2
- Regulation: 21 CFR 876.5220
- 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 K962259 (1996). 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)
- K962259: Libbe Rectal Tube (Formerly a Yankauer Suction Tube), Tiller Mind Body, Inc. (1996) Summary page 1.

## Indications for use
The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K071057
Methodology: https://510kreport.com/methodology