# K173085: invendoscopy E210 System

- Pathway: 510(k) (Traditional)
- Applicant: Invendo Medical GmbH
- Decided: Jan 8, 2018 after 101 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 11 generations back to K894632 (1989). 131 ancestors in all.
No later device cites it as a predicate yet.
3 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161355: invendoscopy E200 System, Invendo Medical GmbH (2016) Summary page 4.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 4.

## Indications for use
The invendoscopy E210 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendoscopy E210 System, the invendoscope SC210, is a sterile single use disposable device. The invendoscope SC210 cannot be reprocessed.

Source page: https://510kreport.com/device/K173085
Methodology: https://510kreport.com/methodology