# K190669: Endotics

- Pathway: 510(k) (Traditional)
- Applicant: Era Endoscopy S.R.L.
- Decided: Jan 3, 2020 after 294 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). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141286: Aer-O-Scope Colonoscope System, Gi View, Ltd. (2014) Summary page 4.
- K121582: Invendo C25 Colonoscopy System, Invendo Medical Gbmh (2012) Summary page 4.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 4.

## Indications for use
The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.

Source page: https://510kreport.com/device/K190669
Methodology: https://510kreport.com/methodology