Cleared Special

K073399 - TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

K073399 is an FDA 510(k) clearance for TARGETSCAN BIOPSY KIT, manufactured by Envisioneering, LLC. The device is a Class 2 Radiology device with product code FCG cleared through the Special 510(k) pathway after a 17-day FDA review.

K073399 · Envisioneering, LLC · Radiology device
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Dec 2007
Decision
17d
Days
Class 2
Risk

K073399 is an FDA 510(k) clearance for the TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Envisioneering, LLC (St. Louis, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1075 - 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 Envisioneering, LLC devices

FDA 510(k) Submission Details - K073399

510(k) Number K073399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date December 21, 2007
Days to Decision 17 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCG Biopsy Needle

All 71
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K073399.
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