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FDA 510(k)

FUJIFILM Surgical System

K-Number: K162836 · 2017-03-13

ApplicantFujifilm New Development U.S.A., Inc.
Decision Date2017-03-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Surgical System is a medical device manufactured by Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2017-03-13 under approval number K162836. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Surgical System?

FUJIFILM Surgical System is a medical device that received FDA 510(k) clearance on 2017-03-13. It is manufactured by Fujifilm New Development U.S.A., Inc.. The 510(k) number is K162836.

When was FUJIFILM Surgical System approved by the FDA?

FUJIFILM Surgical System received FDA 510(k) clearance on 2017-03-13, under approval number K162836.

What company makes FUJIFILM Surgical System?

FUJIFILM Surgical System is manufactured by Fujifilm New Development U.S.A., Inc..

What is the FDA product code for FUJIFILM Surgical System?

The FDA product code for FUJIFILM Surgical System is GCJ.

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 Fujifilm New Development U.S.A., Inc.

K170084InterLock Trocar K180414EPX-4440FN Digital Video Processor with Light Source

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Official Source

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

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