# K183416: Rhino-Laryngo Videoscope Olympus ENF-VT3

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 6, 2019 after 270 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 1 (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). 21 ancestors in all.
No later device cites it as a predicate yet.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 5.

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0332-2024: 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, and other ancillary equipment for endoscopic diagnosis and treatment. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea). This instrument is intended for use in a clinical or ambulatory medical environment.

Source page: https://510kreport.com/device/K183416
Methodology: https://510kreport.com/methodology