Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SCOUT MD Surgical Guidance System

K-Number: K231468 · 2024-02-12

ApplicantMerit Medical System, Inc.
Decision Date2024-02-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCOUT MD Surgical Guidance System is a medical device manufactured by Merit Medical System, Inc.. It received FDA 510(k) clearance on 2024-02-12 under approval number K231468. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOUT MD Surgical Guidance System?

SCOUT MD Surgical Guidance System is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Merit Medical System, Inc.. The 510(k) number is K231468.

When was SCOUT MD Surgical Guidance System approved by the FDA?

SCOUT MD Surgical Guidance System received FDA 510(k) clearance on 2024-02-12, under approval number K231468.

What company makes SCOUT MD Surgical Guidance System?

SCOUT MD Surgical Guidance System is manufactured by Merit Medical System, Inc..

What is the FDA product code for SCOUT MD Surgical Guidance System?

The FDA product code for SCOUT MD Surgical Guidance System is NEU.

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 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 NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION

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: 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) 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)

Other Devices by Merit Medical System, Inc.

K193571Go2Wire Guide Wire K212817Merit Siege Vascular Plug K230636Maestro Microcatheter K252527Surfacer Inside-Out Access Catheter System

Related Devices (Code: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, LLC

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.

↑