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FDA 510(k)

Revolve Surgical System

K-Number: K243968 · 2025-10-03

ApplicantRevolve Surgical, Inc.
Decision Date2025-10-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Revolve Surgical System is a medical device manufactured by Revolve Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-03 under approval number K243968. 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 Revolve Surgical System?

Revolve Surgical System is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Revolve Surgical, Inc.. The 510(k) number is K243968.

When was Revolve Surgical System approved by the FDA?

Revolve Surgical System received FDA 510(k) clearance on 2025-10-03, under approval number K243968.

What company makes Revolve Surgical System?

Revolve Surgical System is manufactured by Revolve Surgical, Inc..

What is the FDA product code for Revolve Surgical System?

The FDA product code for Revolve 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: 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)

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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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