# K112680: Evis Exera Iii Video System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 16, 2012 after 155 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (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). 29 ancestors in all.
57 later devices descend from it; 5 cite it directly.
4 of 87 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.
- K011151: Evis Exera Gastrointestinal Videoscope Gif-Q160Z, The Olympus Optical Co. (2001) Summary page 2.
- K002749: Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13D, The Olympus Optical Co. (2000) Summary page 2.
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 3.
- K062049: Evis Exera II 180 System, Olympus Medical Systems Corporation (2006) Summary page 3.

## Most influential descendants
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 (2013), 19 descendants of its own
- K122831: Video System Center (2012), 19 descendants of its own
- K163675: Processor VP-7000, Light Source BL-7000 (2017), 12 descendants of its own
- K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (2015), 7 descendants of its own
- K131780: Evis Exera Iii Video System (2013), 7 descendants of its own

## Recalls of this device
- Jan 11, 2024 · Class II · Z-1211-2024: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock
- Jan 11, 2024 · Class II · Z-1207-2024: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock
- Jan 11, 2024 · Class II · Z-1206-2024: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock
- Oct 2, 2023 · Class II · Z-0288-2024: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
- 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
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190I/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Source page: https://510kreport.com/device/K112680
Methodology: https://510kreport.com/methodology