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FDA 510(k)

Surgical Drive System (Model: ES70, ES90, E8)

K-Number: K240340 · 2024-07-18

ApplicantGuangdong Jinme Medical Technology Co., Ltd.
Decision Date2024-07-18
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Drive System (Model: ES70, ES90, E8) is a medical device manufactured by Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-18 under approval number K240340. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Drive System (Model: ES70, ES90, E8)?

Surgical Drive System (Model: ES70, ES90, E8) is a medical device that received FDA 510(k) clearance on 2024-07-18. It is manufactured by Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K240340.

When was Surgical Drive System (Model: ES70, ES90, E8) approved by the FDA?

Surgical Drive System (Model: ES70, ES90, E8) received FDA 510(k) clearance on 2024-07-18, under approval number K240340.

What company makes Surgical Drive System (Model: ES70, ES90, E8)?

Surgical Drive System (Model: ES70, ES90, E8) is manufactured by Guangdong Jinme Medical Technology Co., Ltd..

What is the FDA product code for Surgical Drive System (Model: ES70, ES90, E8)?

The FDA product code for Surgical Drive System (Model: ES70, ES90, E8) is DZI.

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 NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait 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

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 Guangdong Jinme Medical Technology Co., Ltd.

K170236Dental Low-speed Turbine Handpiece K170229Dental High-speed Turbine Handpiece K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

Related Devices (Code: DZI)

K152125Oral Surgery System and AccessoriesBonart Co., Ltd. K172137PIEZOTOME CUBESatelec - Acteon Group K171326Piezosurgery WhiteMectron S.P.A. K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A. K192561TRAUS SUS20Saeshin Precision Co., Ltd. K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC

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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