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FDA 510(k)

TSolution One w/ACG+ Surgical System

K-Number: K153647 · 2016-02-16

ApplicantTHINK Surgical, Inc.
Decision Date2016-02-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TSolution One w/ACG+ Surgical System is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2016-02-16 under approval number K153647. 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 TSolution One w/ACG+ Surgical System?

TSolution One w/ACG+ Surgical System is a medical device that received FDA 510(k) clearance on 2016-02-16. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K153647.

When was TSolution One w/ACG+ Surgical System approved by the FDA?

TSolution One w/ACG+ Surgical System received FDA 510(k) clearance on 2016-02-16, under approval number K153647.

What company makes TSolution One w/ACG+ Surgical System?

TSolution One w/ACG+ Surgical System is manufactured by THINK Surgical, Inc..

What is the FDA product code for TSolution One w/ACG+ Surgical System?

The FDA product code for TSolution One w/ACG+ Surgical System is OLO.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

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: 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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by THINK Surgical, Inc.

K162195TSolution One Cup1 Surgical System K170430TSolution One Surgical System Model 210 K193135TSolution One Total Knee Application K191369TSolution One Total Knee Application K180127TCAT (R) THA Instrument Tray Set K203040TSolution One Total Knee Application

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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.

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