Cleared Traditional

K170026 - Radiopaque Tissue Marker

K170026 is an FDA 510(k) clearance for Radiopaque Tissue Marker, manufactured by Viscus Biologics, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K170026 · Viscus Biologics, LLC · General & Plastic Surgery device
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Jun 2017
Decision
150d
Days
Class 2
Risk

K170026 is an FDA 510(k) clearance for the Radiopaque Tissue Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Viscus Biologics, LLC (Cleveland, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 150 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Viscus Biologics, LLC devices

FDA 510(k) Submission Details - K170026

510(k) Number K170026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date June 02, 2017
Days to Decision 150 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEU Marker, Radiographic, Implantable

All 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K170026.
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Star Tissue Marker
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UltraCor Twirl Breast Tissue Marker
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HydroMARK Breast Biopsy Site Marker
K161021 · Devicor Medical Products, Inc. · May 2016