# K181240: Rhino-Laryngo Fiberscope Olympus ENF-GP2

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 4, 2018 after 147 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: 4 generations back to K931154 (1993). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment, Olympus Optical Co., Ltd. (2001) Summary page 5.

## Most influential descendants
- K221660: Rhino-Laryngofiberscope Olympus Enf Type-XP (2022), 0 descendants of its own

## Recalls of this device
- May 5, 2020 · Class II · Z-2292-2020: Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

## Indications for use
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.

Source page: https://510kreport.com/device/K181240
Methodology: https://510kreport.com/methodology