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FDA 510(k)

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM

K-Number: K153063 · 2016-04-08

ApplicantTeleflexmedical, Inc.
Decision Date2016-04-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153063. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K153063.

When was PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM approved by the FDA?

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM received FDA 510(k) clearance on 2016-04-08, under approval number K153063.

What company makes PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is manufactured by Teleflexmedical, Inc..

What is the FDA product code for PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM?

The FDA product code for PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM is GEI.

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 NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED

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)

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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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