Cleared Traditional

K101887 - CONFIDENT SURGERY SUITE 300, MODEL CSS300 (FDA 510(k) Clearance)

Class I Radiology device.

K101887 · Surgiceye GmbH · Radiology device
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Mar 2011
Decision
259d
Days
Class 1
Risk

K101887 is an FDA 510(k) clearance for the CONFIDENT SURGERY SUITE 300, MODEL CSS300. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Surgiceye GmbH (Munich, Bavaria, DE). The FDA issued a Cleared decision on March 22, 2011 after a review of 259 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgiceye GmbH devices

Submission Details

510(k) Number K101887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2010
Decision Date March 22, 2011
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 107d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.