Class Class II
PVC Hydrophilic Urethral Catheter (K220722)
Description
PVC Hydrophilic Urethral Catheter by Well Lead Medical Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220722
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeEZD
Regulation Number876.5130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220722
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. PVC Hydrophilic Urethral Catheter (K220722) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | Well Lead Medical Co., Ltd. | 2014 |
| K062444 | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CAT... | Oasis Medikal Urunler Kimya Sanayi ... | 2007 |
Trace the full predicate network for K220722
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.