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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2024-06-04 under 510(k) 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. The listed applicant is Monteris Medical,. The 510(k) number is K240877.

When did Monteris Medical NeuroBlate System receive FDA 510(k) clearance?

Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240877.

Who is the listed applicant for Monteris Medical NeuroBlate System?

The FDA 510(k) record lists Monteris Medical, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monteris Medical NeuroBlate System?

The FDA product code for Monteris Medical NeuroBlate System is ONO.

Other records listing Monteris Medical, as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260976NeuroBlate SystemK231061NeuroBlate SystemK222983NeuroBlate Fusion-S Software V3.17K201056NeuroBlate SystemK193375NeuroBlate SystemK182036NeuroBlate System

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Related Devices (Code: ONO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260976NeuroBlate SystemMonteris MedicalK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)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, ABK250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic NavigationK214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, ABK211269Visualase MRI-Guided Laser Ablation System (SW 3.4)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.

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