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FDA 510(k)

TMINI® Miniature Robotic System

K-Number: K260010 · 2026-03-03

ApplicantTHINK Surgical, Inc.
Decision Date2026-03-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TMINI® Miniature Robotic System is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2026-03-03 under approval number K260010. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMINI® Miniature Robotic System?

TMINI® Miniature Robotic System is a medical device that received FDA 510(k) clearance on 2026-03-03. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K260010.

When was TMINI® Miniature Robotic System approved by the FDA?

TMINI® Miniature Robotic System received FDA 510(k) clearance on 2026-03-03, under approval number K260010.

What company makes TMINI® Miniature Robotic System?

TMINI® Miniature Robotic System is manufactured by THINK Surgical, Inc..

What is the FDA product code for TMINI® Miniature Robotic System?

The FDA product code for TMINI® Miniature Robotic System is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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