Class Class II
HandX Instrument – Monopolar Spatula (K222011)
Description
HandX Instrument - Monopolar Spatula by Human Xtensions , Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222011
Clearance Date2023-01-12
Clearance TypeSpecial
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222011
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 Instrument – Monopolar Spatula (K222011) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203603 | Monopolar Hook | Human Xtensions , Ltd. | 2021 |
| K160128 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2016 |
Trace the full predicate network for K222011
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.