# K092829: Insertease

- Pathway: 510(k) (Traditional)
- Applicant: Christcot Medical Company
- Decided: Dec 2, 2009 after 78 days
- Product code: OOW (Applicator For Rectal Suppository)
- Device class: 1
- Regulation: 21 CFR 876.4730
- 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. The FDA summary names its predicate without a number.
- (no number) Vaginal Applicator: named in the summary without a submission number
- (no number) Enema Kit: named in the summary without a submission number
- (no number) Rectal Dilator: named in the summary without a submission number

## Indications for use
InsertEaseTM is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum.

Source page: https://510kreport.com/device/K092829
Methodology: https://510kreport.com/methodology