# K093037: Pentex EC-3890LI

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Dec 28, 2009 after 90 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: 2 generations back to K822846 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951574: EC-3800L, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.

## Indications for use
The EC-3890L-1, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutid access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K093037
Methodology: https://510kreport.com/methodology