Class Class II
TMINI Miniature Robotic System (K243481)
Description
TMINI Miniature Robotic System by THINK Surgical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243481
Clearance Date2025-01-06
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243481
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. TMINI Miniature Robotic System (K243481) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 |
| K232802 | TMINIĀ Miniature Robotic System | THINK Surgical, Inc. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025 |
Trace the full predicate network for K243481
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.