Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TMINI Miniature Robotic System

K-Number: K253661 · 2025-12-22

ApplicantTHINK Surgical, Inc.
Decision Date2025-12-22
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 2025-12-22 under approval number K253661. 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 2025-12-22. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K253661.

When was TMINI Miniature Robotic System approved by the FDA?

TMINI Miniature Robotic System received FDA 510(k) clearance on 2025-12-22, under approval number K253661.

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

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07566767 Effect of Robotic Gait on Functions in Cerebral Palsy COMPLETED

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)

Other Devices by THINK Surgical, Inc.

K162195TSolution One Cup1 Surgical System K153647TSolution One w/ACG+ Surgical System K170430TSolution One Surgical System Model 210 K193135TSolution One Total Knee Application K191369TSolution One Total Knee Application K180127TCAT (R) THA Instrument Tray Set

View all 21 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑