# K042741: EC-3870CILK, Confocal Video Colonoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Oct 19, 2004 after 15 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822846 (1982). 5 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 21 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.
- K912581: Zeiss Confocal Laser Scanning Ophthalmoscope (Clso), Carl Zeiss, Inc. (1991) Summary page 1.

## Most influential descendants
- K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex (2006), 13 descendants of its own
- K051585: F-400 System (2005), 13 descendants of its own
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), 12 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2069-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- Apr 6, 2016 · Class II · Z-2276-2016: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

## Indications for use
The EC-3870CILK, Confocal Video Colonoscope, is intended to provide optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor), 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/K042741
Methodology: https://510kreport.com/methodology