# K183053: Olympus Small Intestinal Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 5, 2019 after 123 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K090210 (2009). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173459: Olympus Small Intestinal Capsule Endoscope System, Olympus Medical Systems Corp. (2018) Summary page 5.

## Indications for use
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy. The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding, bleeding, angioectasia, red spot, ulcer or erosion. The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.

Source page: https://510kreport.com/device/K183053
Methodology: https://510kreport.com/methodology