Visualase MRI-Guided Laser Ablation System (SW 3.4)— 510(k) K211269

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K211269 for Visualase MRI-Guided Laser Ablation System (SW 3.4), Substantially Equivalent on 2022-01-07. Applicant: Medtronic Navigation, Inc..

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code ONO
Advisory panel: General, Plastic Surgery
Date received: 2021-04-27
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

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