# K973256: Jimmy John Iii Rectal Nozzle

- Pathway: 510(k) (Traditional)
- Applicant: Colon Therapeutics
- Decided: Sep 29, 1997 after 35 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050992: Conmed Irrigation Nozzle (2005), 0 descendants of its own

## Indications for use
Intended for use in Colon Imgation with any colon irrigaticn system. Class 11 - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Source page: https://510kreport.com/device/K973256
Methodology: https://510kreport.com/methodology