SURGIVISIO Device— 510(k) K220627

Name: FDA 510(k) clearance K220627
Creator: U.S. Food and Drug Administration
Published: 2022-03-18

Substantially Equivalent

Ecential Robotics

FDA 510(k) clearance K220627 for SURGIVISIO Device, Substantially Equivalent on 2022-03-18. Applicant: Ecential Robotics. Device class: 2.

Clearance details

Applicant: Ecential Robotics
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2022-03-04
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Gieres, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWB

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K253726 — uAngio AVIVA CX2026-08-21
K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

More clearances from Ecential Robotics

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K261113 — Op.n Spine Navigation and Robotic Guidance2026-07-22
K242914 — Op.n(TM) Navigation2025-03-07
K233228 — Spine Navigation and Robotic-Assistance Device2024-06-14
K231886 — SURGIVISIO Device2023-07-27
K221028 — SURGIVISIO Device2022-07-06

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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