Cleared Traditional

K101887 - CONFIDENT SURGERY SUITE 300

K101887 is an FDA 510(k) clearance for CONFIDENT SURGERY SUITE 300, manufactured by Surgiceye GmbH. The device is a Class 1 Radiology device with product code IZD cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

FDA 510(k) Submission Details - K101887

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.

IZD Device Classification - Class 1, General Controls

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.