# K974042: Amsure Cleansing Enema Set

- Pathway: 510(k) (Traditional)
- Applicant: Amsino Intl., Inc.
- Decided: Dec 19, 1997 after 56 days
- Product code: FCE (Enema Kit)
- Device class: 1
- Regulation: 21 CFR 876.5210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

Source page: https://510kreport.com/device/K974042
Methodology: https://510kreport.com/methodology