Class Class II
ENDOFLATOR + (K250388)
Description
ENDOFLATOR + by Karl Storz SE & CO. KG, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250388
Clearance Date2025-09-22
Clearance TypeTraditional
Product CodeHIF
Regulation Number884.1730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250388
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. ENDOFLATOR + (K250388) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | 2026 |
Trace the full predicate network for K250388
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.