Class Class II
TMINI Miniature Robotic System (K253661)
Description
TMINI Miniature Robotic System by THINK Surgical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK253661
Clearance Date2025-12-22
Clearance TypeSpecial
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K253661
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 (K253661) 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 |
|---|---|---|---|
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026 |
Trace the full predicate network for K253661
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.