Class Class II
Insufflator (K222812)
Description
Insufflator by Scivita Medical Technology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222812
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeHIF
Regulation Number884.1730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222812
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. Insufflator (K222812) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016 |
| K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | W.O.M. World of Medicine AG | 2004 |
Trace the full predicate network for K222812
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.