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FDA 510(k)

Outlook Surgical Versa One System (8900139)

K-Number: K241731 · 2025-08-11

ApplicantResnent, LLC
Decision Date2025-08-11
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Outlook Surgical Versa One System (8900139) is a medical device manufactured by Resnent, LLC. It received FDA 510(k) clearance on 2025-08-11 under approval number K241731. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Outlook Surgical Versa One System (8900139)?

Outlook Surgical Versa One System (8900139) is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Resnent, LLC. The 510(k) number is K241731.

When was Outlook Surgical Versa One System (8900139) approved by the FDA?

Outlook Surgical Versa One System (8900139) received FDA 510(k) clearance on 2025-08-11, under approval number K241731.

What company makes Outlook Surgical Versa One System (8900139)?

Outlook Surgical Versa One System (8900139) is manufactured by Resnent, LLC.

What is the FDA product code for Outlook Surgical Versa One System (8900139)?

The FDA product code for Outlook Surgical Versa One System (8900139) is EOB.

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)

Related Devices (Code: EOB)

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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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