# K080764: Success Cecal Intubation Assist, Model: 4100

- Pathway: 510(k) (Traditional)
- Applicant: Max Endoscopy, Inc.
- Decided: May 6, 2008 after 49 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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
The single-use disposable device is intended to allow the physician to temporarily increase the stiffness of a colonoscope when extra rigidity is required.

Source page: https://510kreport.com/device/K080764
Methodology: https://510kreport.com/methodology