Monteris Medical NeuroBlate System
K-Number: K240877 · 2024-06-04
ApplicantMonteris Medical,
Decision Date2024-06-04
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Monteris Medical NeuroBlate System is a medical device manufactured by Monteris Medical,. It received FDA 510(k) clearance on 2024-06-04 under approval number K240877. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Monteris Medical NeuroBlate System?
Monteris Medical NeuroBlate System is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Monteris Medical,. The 510(k) number is K240877.
When was Monteris Medical NeuroBlate System approved by the FDA?
Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2024-06-04, under approval number K240877.
What company makes Monteris Medical NeuroBlate System?
Monteris Medical NeuroBlate System is manufactured by Monteris Medical,.
What is the FDA product code for Monteris Medical NeuroBlate System?
The FDA product code for Monteris Medical NeuroBlate System is ONO.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT05754281
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
ACTIVE_NOT_RECRUITING
Related PubMed Literature
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 42174947
Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks.
Studies in health technology and informatics (2026)
PMID: 42056377
Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.
Scientific reports (2026)
PMID: 41879133
Medical Device Regulation - Who Does the FDA Serve?
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)
Other Devices by Monteris Medical,
Related Devices (Code: ONO)
K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB
K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.
K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)Clinical Laserthermia Systems, AB
K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation
K260976NeuroBlate SystemMonteris Medical
K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)Medtronic Navigation, Inc.
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.