Class Class II
Traus SSG10 Surgical System (K233153)
Description
Traus SSG10 Surgical System by Saeshin Precision Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233153
Clearance Date2024-09-20
Clearance TypeTraditional
Product CodeHBC
Regulation Number882.4360
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233153
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. Traus SSG10 Surgical System (K233153) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 |
Trace the full predicate network for K233153
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.