# K071254: Small Intestinal Videoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Mar 25, 2008 after 326 days
- Product code: FDA (Enteroscope And Accessories)
- 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: 4 generations back to K853585 (1986). 9 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K051551: Small Intestinal Videoscope System, Olympus Medical Systems Corporation (2005) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0343-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten

## 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 an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion. Indications for Use of the Components are as follows: SIF-Q180 SMALL INTESTINAL VIDEOSCOPE This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum colon, and small intestine) by either oral and anal insertion. OBCU Balloon Control Unit This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus-designated small intestinal endoscope.

Source page: https://510kreport.com/device/K071254
Methodology: https://510kreport.com/methodology