# K161355: invendoscopy E200 System

- Pathway: 510(k) (Traditional)
- Applicant: Invendo Medical GmbH
- Decided: Aug 25, 2016 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: 10 generations back to K894632 (1989). 130 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100624: Invendo C20 Colonoscopy System, Invendo Medical Gbmh (2012) Summary page 4.
- K121582: Invendo C25 Colonoscopy System, Invendo Medical Gbmh (2012) Summary page 4.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 4.

## Most influential descendants
- K173085: invendoscopy E210 System (2018), 0 descendants of its own

## Indications for use
The invendoscopy E200 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 E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.

Source page: https://510kreport.com/device/K161355
Methodology: https://510kreport.com/methodology