# K951577: ES-3800, Video Sigmoidoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Mar 21, 1996 after 352 days
- Product code: FAM (Sigmoidoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792341 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792341: Pentax Flexible Sigmoidoscope Mod. FS-34, Pentax Precision Instrument Corp. (1979) 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
- K964131: Endoscope (1997), 0 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2075-2016: 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.

## Indications for use
The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). 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/K951577
Methodology: https://510kreport.com/methodology