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FDA 510(k)

G Surgical Marksman MIS System

K-Number: K161516 · 2016-08-25

ApplicantG Surgical, LLC
Decision Date2016-08-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G Surgical Marksman MIS System is a medical device manufactured by G Surgical, LLC. It received FDA 510(k) clearance on 2016-08-25 under approval number K161516. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G Surgical Marksman MIS System?

G Surgical Marksman MIS System is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by G Surgical, LLC. The 510(k) number is K161516.

When was G Surgical Marksman MIS System approved by the FDA?

G Surgical Marksman MIS System received FDA 510(k) clearance on 2016-08-25, under approval number K161516.

What company makes G Surgical Marksman MIS System?

G Surgical Marksman MIS System is manufactured by G Surgical, LLC.

What is the FDA product code for G Surgical Marksman MIS System?

The FDA product code for G Surgical Marksman MIS System is NKB.

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 G Surgical, LLC

K171834G Surgical OCT Spinal System K193219G Surgical Marksman System K210890GPS Cervical Spacers K230063G Surgical Marksman Spinal Deformity System K240737G Surgical Marksman MIS System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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