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

FDA 510(k)

Visualase MRI-Guided Laser Ablation System (SW 3.4)

K-Number: K211269 · 2022-01-07

ApplicantMedtronic Navigation, Inc.
Decision Date2022-01-07
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Visualase MRI-Guided Laser Ablation System (SW 3.4) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211269. 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 Visualase MRI-Guided Laser Ablation System (SW 3.4)?

Visualase MRI-Guided Laser Ablation System (SW 3.4) is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K211269.

When did Visualase MRI-Guided Laser Ablation System (SW 3.4) receive FDA 510(k) clearance?

Visualase MRI-Guided Laser Ablation System (SW 3.4) received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211269.

Who is the listed applicant for Visualase MRI-Guided Laser Ablation System (SW 3.4)?

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

What is the FDA product code for Visualase MRI-Guided Laser Ablation System (SW 3.4)?

The FDA product code for Visualase MRI-Guided Laser Ablation System (SW 3.4) is ONO.

Related Clinical Trials

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.

NCT02759744Fusion Guided Focal Laser Ablation of Prostate CancerENROLLING_BY_INVITATIONNCT03650595MRI Guided Focal Laser Ablation of Prostate CancerRECRUITINGNCT04305925Focal Laser Ablation of Prostate CancerCOMPLETEDNCT02386137Factors Influencing Volumetric MR-HIFU Ablation of Uterine FibroidsCOMPLETEDNCT04808427Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate CancerSUSPENDEDNCT06817733Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion ImagingRECRUITING

Other records listing Medtronic Navigation, Inc. 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.

K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

View all 33 devices →

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 NavigationK240877Monteris Medical NeuroBlate SystemMonteris Medical,K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB

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.

↑