Class Class II
SimPro™ Now, GentleCath™ Hydrophilic (K223756)
Description
SimPro™ Now, GentleCath™ Hydrophilic by Dentsply Sirona, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223756
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeEZD
Regulation Number876.5130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223756
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. SimPro™ Now, GentleCath™ Hydrophilic (K223756) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016 |
| K062444 | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CAT... | Oasis Medikal Urunler Kimya Sanayi ... | 2007 |
Trace the full predicate network for K223756
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.