# K131780: Evis Exera Iii Video System

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Aug 29, 2013 after 73 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 30 ancestors in all.
7 later devices descend from it; 4 cite it directly.
4 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112680: Evis Exera Iii Video System, Olympus Medical Systems Corporation (2012) Summary page 1.

## Most influential descendants
- K222584: Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I, Gastrointestinal Videoscope Olympus Gif-1100 (2023), 2 descendants of its own
- K222861: EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 (2023), 1 descendant of its own
- K250862: Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190); Evis Exera Iii Bronchovideoscope (Olympus BF-XT190); Bronchovideoscope (Olympus BF-H1100); Bronchovideoscope (Olympus BF-1TH1100) (2025), 0 descendants of its own
- K243261: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (2025), 0 descendants of its own
- K250432: Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (2025), 0 descendants of its own

## Recalls of this device
- Jan 11, 2024 · Class II · Z-1210-2024: 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 16, 2023 · Class II · Z-0416-2024: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre
- Oct 16, 2023 · Class II · Z-0417-2024: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre
- Oct 16, 2023 · Class II · Z-0418-2024: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre
- Oct 16, 2023 · Class II · Z-0419-2024: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre
- Oct 16, 2023 · Class II · Z-0415-2024: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre
- Sep 25, 2023 · Class II · Z-0341-2024: 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 14, 2023 · Class II · Z-0056-2025: Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

## Indications for use
Endoscoies (GASTROINTESTINAL VIDEOSCOPE GIF-HI1190. GIF-HOI 90. COLONOVIDEOSCOPE CF-HQl SOIl. CF-HI9SOLI. PCF-HI9OUJI. PCF-PHI9OLtIf This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-H01901Jl1), 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 Ill COLONOVIDEOSCOPE CF-H19OLII, CF-HQI9OLII, POF-PH19OLI, PCF-H1SOLJI are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). CV-1 90 VIDEO SYSTEM CENTER This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, Endomherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. CLV-l90 XENON LIGHT SOURCE 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/K131780
Methodology: https://510kreport.com/methodology