# K951574: EC-3800L, Video Colonoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Mar 21, 1996 after 352 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822846 (1982). 3 ancestors in all.
72 later devices descend from it; 8 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822846: Pentax FC-38LA & FC-38SA Colonofiber, Pentax Precision Instrument Corp. (1982) Summary page 1.
- K934920: VB-1830/VB-1530, Video Bronchoscope, Pentax Precision Instrument Corp. (1994) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Most influential descendants
- K961570: Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length) (1996), 39 descendants of its own
- K032688: Colonosight Model 510B (2004), 38 descendants of its own
- K042741: EC-3870CILK, Confocal Video Colonoscope (2004), 15 descendants of its own
- K091305: Clearpath (2009), 13 descendants of its own
- K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex (2006), 13 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2068-2016: 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-2275-2016: 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.
- Apr 6, 2016 · Class II · Z-2278-2016: 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-3800L, Video Colonoscope, is intended to provide optical visualization 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/K951574
Methodology: https://510kreport.com/methodology