# K031256: Xsif-1TQ140A Small Intestinal Videoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Opto-Electronics Co., Ltd.
- Decided: Jul 23, 2003 after 93 days
- Product code: FDA (Enteroscope And Accessories)
- 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 K853585 (1986). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904800: SIF-SW, Olympus Corp. (1991). Our OCR of the scanned summary read K304800, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SIF-SW Sonde-type Small Intestinal Fiberscope”.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 5.
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 5.
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 5.
- (no number) SIF-B Small Intestinal Fiberscope: named in the summary without a submission number

## Most influential descendants
- K051551: Small Intestinal Videoscope System (2005), 4 descendants of its own
- 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
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE This instrument has been designed to be used with the OLYMPUS EVIS Video System Center, EVIS Universal Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the small intestine. XBO1-681-26 STYLET This product has been designed to increase stiffness of insertion part of Olympus small intestinal videoscope XSIF-1TQ140A by inserting to the endoscope biopsy channel. ST-S1 SPLINTING TUBE This product has been designed to be used with the XSIF-1TQ140A for endoscopy within the small intestinal tract. This product is intended to facilitate insertion of the scope by straightening from the esophagus through stomach to descending part of duodenum.

Source page: https://510kreport.com/device/K031256
Methodology: https://510kreport.com/methodology