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FDA 510(k)

TMINI Miniature Robotic System

K-Number: K242264 · 2024-08-23

ApplicantTHINK Surgical, Inc.
Decision Date2024-08-23
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 2024-08-23 under approval number K242264. 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 2024-08-23. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K242264.

When was TMINI Miniature Robotic System approved by the FDA?

TMINI Miniature Robotic System received FDA 510(k) clearance on 2024-08-23, under approval number K242264.

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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