# K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I

- Pathway: 510(k) (Special)
- Applicant: The Olympus Optical Co.
- Decided: May 9, 2000 after 21 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
258 later devices descend from it; 15 cite it directly.
5 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051645: Evis Exera 160A System (2005), 208 descendants of its own
- K062049: Evis Exera II 180 System (2006), 158 descendants of its own
- K061313: Evis Exera 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- K112680: Evis Exera Iii Video System (2012), 57 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0329-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten

## Indications for use
The EVIS EXERA Colonovideoscopes CF-Q160 AL/l and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, sigmoid colon, colon and ileocecal valve).

Source page: https://510kreport.com/device/K001241
Methodology: https://510kreport.com/methodology