Class Class II
LapBox Power Tissue Containment System (K250212)
Description
LapBox Power Tissue Containment System by Ark Surgical, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250212
Clearance Date2025-04-15
Clearance TypeTraditional
Product CodePMU
Regulation Number884.4050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250212
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. LapBox Power Tissue Containment System (K250212) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221365 | LapBox Tissue Containment Removal System | Ark Surgical, Ltd. | 2022 |
| K192898 | PneumoLiner | Advanced Surgical Concepts | 2020 |
Trace the full predicate network for K250212
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.