# K961563: EC-384OTL, Video Colonscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jun 19, 1996 after 57 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.
39 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951579: EC-3800TL, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Most influential descendants
- K032688: Colonosight Model 510B (2004), 38 descendants of its own
- K091305: Clearpath (2009), 13 descendants of its own
- K052930: Navigator Endoscopy System (2006), 13 descendants of its own
- K070622: Neoguide Endoscopy System (2007), 12 descendants of its own
- K093779: Clearpath Ugi (2010), 10 descendants of its own

## Indications for use
The EC-3840TL, Video Colonscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K961563
Methodology: https://510kreport.com/methodology