# K100584: Evis Exeraii 180 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 2, 2010 after 122 days
- Product code: NWB (Endoscope, Accessories, Narrow Band Spectrum)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 27 ancestors in all.
132 later devices descend from it; 22 cite it directly.
7 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 2.
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.
- K062049: Evis Exera II 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.

## Most influential descendants
- K112680: Evis Exera Iii Video System (2012), 57 descendants of its own
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 (2012), 34 descendants of its own
- 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
- K140149: Epx-4440HD Digital Video Processor (2014), 16 descendants of its own

## Recalls of this device
- Jan 11, 2024 · Class II · Z-1208-2024: 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-1209-2024: 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-1214-2024: 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-1205-2024: 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
- 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
- Dec 21, 2022 · Class II · Z-1132-2023: A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contaminat
- Apr 22, 2022 · Class II · Z-1274-2022: A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices m
- Dec 17, 2018 · Class II · Z-1009-2019: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing oper

## Indications for use
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180. This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndloTherapy accessories (such as a biopsy forceps), and other ancillary equipment for transoral or transnasal endloscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180. OLYMPUS GIF TYPE H180 These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endloscopy and endloscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL. OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI. OLYMPUS PCF TYPE Q180AL (Pediatric). OLYMPUS PCF TYPE Q180AI (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric). OLYMPUS PCF TYPE H180AI (Pediatric), These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endloscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Source page: https://510kreport.com/device/K100584
Methodology: https://510kreport.com/methodology