Class Class II
Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173)
Description
Saneso Lens Wash Bottle Assembly (SAN-LWB-A) by Saneso, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222173
Clearance Date2023-02-27
Clearance TypeTraditional
Product CodeOCX
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222173
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band I... | Saneso, Inc. | 2022 |
Trace the full predicate network for K222173
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.