Cleared Special

K061865 - FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05

K061865 is an FDA 510(k) clearance for FLEX 10 MIS ABLATION PROBE, manufactured by Guidant Corp.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 24-day FDA review.

K061865 · Guidant Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
24d
Days
Class 2
Risk

K061865 is an FDA 510(k) clearance for the FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on July 27, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device 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.

FDA 510(k) Submission Details - K061865

510(k) Number K061865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date July 27, 2006
Days to Decision 24 days
Submission Type Special
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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - NEY System, Ablation, Microwave And Accessories

All 68
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K061865.
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K070023 · Microsurgeon, Inc. · Aug 2007
VIVAWAVE MICROWAVE ABLATION SYSTEM
K053535 · Valleylab · Apr 2006
MICROSULIS TISSUE ABLATION SYSTEM
K052919 · Microsulis Americas, Inc. · Jan 2006
GUIDANT MICROWAVE ABLATION SYSTEM
K041340 · Guidant Corporation, Cardiac Surgery · Jul 2004
K061865 · FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
Download PDF FDA Summary Guidant Corp.