Class Class II
SonoPlex STIM; SonoPlex II (K243682)
Description
SonoPlex STIM; SonoPlex II by PAJUNK GmbH Medizintechnologie, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243682
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeBSP
Regulation Number868.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243682
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. SonoPlex STIM; SonoPlex II (K243682) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | 2024 |
| K111374 | SONO-SERIES CORNERSTONE TECHNIQUE | PAJUNK GmbH Medizintechnologie | 2011 |
Trace the full predicate network for K243682
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.