Class Class II
HandX™ Self-Righting Needle Holder (K223718)
Description
HandX™ Self-Righting Needle Holder by Human Xtensions , Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223718
Clearance Date2023-06-05
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223718
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. HandX™ Self-Righting Needle Holder (K223718) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173919 | HX Device | Human Extension , Ltd. | 2018 |
Trace the full predicate network for K223718
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.