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FDA 510(k)

Practical Navigation Surgical Guidance System (PNSGS)

K-Number: K202184 · 2021-02-24

ApplicantPractical Navigation, LLC
Decision Date2021-02-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Practical Navigation Surgical Guidance System (PNSGS) is a medical device manufactured by Practical Navigation, LLC. It received FDA 510(k) clearance on 2021-02-24 under approval number K202184. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Practical Navigation Surgical Guidance System (PNSGS)?

Practical Navigation Surgical Guidance System (PNSGS) is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by Practical Navigation, LLC. The 510(k) number is K202184.

When was Practical Navigation Surgical Guidance System (PNSGS) approved by the FDA?

Practical Navigation Surgical Guidance System (PNSGS) received FDA 510(k) clearance on 2021-02-24, under approval number K202184.

What company makes Practical Navigation Surgical Guidance System (PNSGS)?

Practical Navigation Surgical Guidance System (PNSGS) is manufactured by Practical Navigation, LLC.

What is the FDA product code for Practical Navigation Surgical Guidance System (PNSGS)?

The FDA product code for Practical Navigation Surgical Guidance System (PNSGS) is OLO.

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 NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07614607 Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial 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: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

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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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