# K222173: Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

- Pathway: 510(k) (Traditional)
- Applicant: Saneso, Inc.
- Decided: Feb 27, 2023 after 221 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210052: Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Gastroscope-A  (Model: with/without Select Band Imaging (SBI)), Saneso, Inc. (2022) Summary page 4.

## Indications for use
The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes. It facilitates the following: 1. Sterile water for lens wash function 2. Air / CO2 for luminal insufflation function

Source page: https://510kreport.com/device/K222173
Methodology: https://510kreport.com/methodology