# K192793: Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jul 17, 2020 after 291 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131780: Evis Exera Iii Video System, Olympus Medical Systems Corp. (2013) Summary page 5.

## Recalls of this device
- Jan 11, 2024 · Class II · Z-1212-2024: 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-1213-2024: 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-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

## Indications for use
This instrument is intended 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 endoscopic surgery. The EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, 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 COLONOVIDEOSCOPE PCF-HQ190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Source page: https://510kreport.com/device/K192793
Methodology: https://510kreport.com/methodology