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FDA 510(k)

Traus SSG10 Surgical System

K-Number: K233153 · 2024-09-20

ApplicantSaeshin Precision Co., Ltd.
Decision Date2024-09-20
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Traus SSG10 Surgical System is a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under approval number K233153. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Traus SSG10 Surgical System?

Traus SSG10 Surgical System is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K233153.

When was Traus SSG10 Surgical System approved by the FDA?

Traus SSG10 Surgical System received FDA 510(k) clearance on 2024-09-20, under approval number K233153.

What company makes Traus SSG10 Surgical System?

Traus SSG10 Surgical System is manufactured by Saeshin Precision Co., Ltd..

What is the FDA product code for Traus SSG10 Surgical System?

The FDA product code for Traus SSG10 Surgical System is HBC.

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 Saeshin Precision Co., Ltd.

K171436STRONG Dental Handpieces K182892TRAUS Dental Handpieces K181129STRONG Dental Handpieces K192561TRAUS SUS20 K201292TRAUS SIP20 K212043TRAUS ENDO

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Related Devices (Code: HBC)

K152960ELAN 4 Motor SystemAesculap, Inc. K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsMedtronic Powered Surgical Solutions K163565MR8 Drill SystemMedtronic Powered Surgical Solutions K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions K193630hekaDrillZethon, Ltd.

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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