# K111756: V1 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 20, 2012 after 272 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931154 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K100564: EVIS EXERA II Xenon Light Source Olympus CLV-180. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## 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
- Sep 25, 2023 · Class II · Z-0334-2024: 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
VIDEO SYSTEM CENTER CV-V1 This video system center is intend to be used with OLYMPUS camera heads, endloscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endloscopic diagnosis, treatment, and video observation. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndloTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endloscopy and 6ndoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). COLONOVIDEOSCOPE OLYMPUS CF-LV1 L and CF-LV1 I This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileoceca? valve).

Source page: https://510kreport.com/device/K111756
Methodology: https://510kreport.com/methodology