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

Name: FDA 510(k) clearance K211269
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

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.. Device class: 2.

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONO

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K262315 — NeuroBlate System2026-09-03
K260976 — NeuroBlate System2026-04-23
K253391 — Visualase Cooled Laser Applicator System (3 models)2026-03-13
K251298 — Mobile Laser Unit (1001-N2) +3 more2025-09-04
K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)2025-05-29

More clearances from Medtronic Navigation, Inc.

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K253379 — Stealth AXiS Cranial clinical application2026-03-26
K253395 — Stealth AXiS ENT clinical application2026-03-16
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application2026-02-12
K251282 — StealthStation S8 Spine Software2025-10-17
K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts2025-06-05

Recalls naming K211269

K-number listed on FDA's recall record

Z-0244-2023 — Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.Class II·Ongoing·Medtronic Navigation, Inc.·20221014

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211269.

Data sourced from openFDA. This site is unofficial and independent of the FDA.