Cleared Special

K220946 - SURGIVISIO Device

K220946 is an FDA 510(k) clearance for SURGIVISIO Device, manufactured by Ecential Robotics. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 14-day FDA review.

K220946 · Ecential Robotics · Radiology device
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Apr 2022
Decision
14d
Days
Class 2
Risk

K220946 is an FDA 510(k) clearance for the SURGIVISIO Device. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ecential Robotics (Gieres, FR). The FDA issued a Cleared decision on April 15, 2022 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ecential Robotics devices

FDA 510(k) Submission Details - K220946

510(k) Number K220946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2022
Decision Date April 15, 2022
Days to Decision 14 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 245
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