# K051551: Small Intestinal Videoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jun 28, 2005 after 15 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853585 (1986). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 2.
- K031256: Xsif-1TQ140A Small Intestinal Videoscope, Olympus Opto-Electronics Co., Ltd. (2003) Summary page 2.
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 2.

## Most influential descendants
- K071254: Small Intestinal Videoscope System (2008), 3 descendants of its own
- K231323: Ancora-SB (2023), 1 descendant of its own
- K260314: Ancora-SB (2026), 0 descendants of its own
- K091759: Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-H (2009), 0 descendants of its own

## Indications for use
SMALL INTESTINAL VIDEOSCOPE SYSTEM This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.

Source page: https://510kreport.com/device/K051551
Methodology: https://510kreport.com/methodology