FDA 510(k)

Anovo Surgical System (6Ne)

K-Number: K250591 · 2025-06-06

Decision Date2025-06-06

Product CodeQNM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Anovo Surgical System (6Ne) is a medical device manufactured by Momentis Surgical , Ltd.. It received FDA 510(k) clearance on 2025-06-06 under approval number K250591. The device is classified under product code QNM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anovo Surgical System (6Ne)?

Anovo Surgical System (6Ne) is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Momentis Surgical , Ltd.. The 510(k) number is K250591.

When was Anovo Surgical System (6Ne) approved by the FDA?

Anovo Surgical System (6Ne) received FDA 510(k) clearance on 2025-06-06, under approval number K250591.

What company makes Anovo Surgical System (6Ne)?

Anovo Surgical System (6Ne) is manufactured by Momentis Surgical , Ltd..

What is the FDA product code for Anovo Surgical System (6Ne)?

The FDA product code for Anovo Surgical System (6Ne) is QNM.

Related Clinical Trials

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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 Momentis Surgical , Ltd.

DEN190022Hominis Surgical System K232146Anovo Pedestal K242157Anovo Surgical System (Model 6Ne) K241907Anovo Surgical System (model 6N) K251761Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

View all 8 devices →

Related Devices (Code: QNM)

DEN190022Hominis Surgical SystemMomentis Surgical , Ltd. K232146Anovo PedestalMomentis Surgical , Ltd. K242157Anovo Surgical System (Model 6Ne)Momentis Surgical , Ltd. K241907Anovo Surgical System (model 6N)Momentis Surgical , Ltd. K251761Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd. K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , 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.