# K100624: Invendo C20 Colonoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Invendo Medical Gbmh
- Decided: Feb 23, 2012 after 721 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: 8 generations back to K894632 (1989). 108 ancestors in all.
6 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)
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 2.
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 2.
- K032688: Colonosight Model 510B, Sightline Technologies, Ltd. (2004) Summary page 2.
- K052930: Navigator Endoscopy System, Neoguide Systems, Inc. (2006) Summary page 2.
- K070622: Neoguide Endoscopy System, Neoguide Systems, Inc. (2007) Summary page 2.
- K070330: Third Eye Retroscope Auxiliary Endoscopy System, Avantis Medical Systems, Inc. (2007) Summary page 2.
- K092156: Cad 12, Colonoscopy Assist Device, Softscope Medical Technologies, Inc. (2009) Summary page 2.
- K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator, Medela AG (2005) Summary page 2.
- K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057, Medela AG (2002) Summary page 2.
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400, E-Z-Em, Inc. (2003) Summary page 2.
- K060962: Endogator Endoscopy Irrigation Pump, Model Egp-100, Byrne Medical, Inc. (2006) Summary page 2.
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 2.

## Most influential descendants
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- 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

## Indications for use
The invendo C20 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 an ileocecal valve) for endoscopy and endloscopic surgery. The colonoscope component of the invendo C20 Colonoscopy System, the SC20 colonoscope, is a single use disposable device. The SC20 colonoscope cannot be reprocessed.

Source page: https://510kreport.com/device/K100624
Methodology: https://510kreport.com/methodology