# K080317: Enolok-for Endoscoped with 12.8>Dia.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>Dia. 11.5MM Shaft ,Model Pel

- Pathway: 510(k) (Traditional)
- Applicant: Syntheon, LLC
- Decided: Apr 29, 2008 after 83 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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
Longest line of descent: 4 generations back to K993704 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062805: Modification to Endo-Ease, Spirus Medical, Inc. (2006) Summary page 1.

## Indications for use
The EndoLokM T is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.

Source page: https://510kreport.com/device/K080317
Methodology: https://510kreport.com/methodology