# K121582: Invendo C25 Colonoscopy System

- Pathway: 510(k) (Special)
- Applicant: Invendo Medical Gbmh
- Decided: Dec 20, 2012 after 204 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: 9 generations back to K894632 (1989). 109 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 115 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 1.

## Most influential descendants
- K141286: Aer-O-Scope Colonoscope System (2014), 2 descendants of its own
- K161355: invendoscopy E200 System (2016), 1 descendant of its own
- K190669: Endotics (2020), 0 descendants of its own
- K173085: invendoscopy E210 System (2018), 0 descendants of its own
- K161791: Aer-O-Scope Colonoscope System (2016), 0 descendants of its own

## Indications for use
The invendo C25 Colonoscopy 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 invendo C25 Colonoscopy System, the SC20 Colonoscope, is a single use disposable device. The SC20 colonoscope cannot be reprocessed.

Source page: https://510kreport.com/device/K121582
Methodology: https://510kreport.com/methodology