Cleared Traditional

K013946 - FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM

K013946 is an FDA 510(k) clearance for FLEX 10 ACCESSORY FOR THE AFX MICROWAVE..., manufactured by Afx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013946 · Afx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
90d
Days
Class 2
Risk

K013946 is an FDA 510(k) clearance for the FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Afx, Inc. (Fremont, US). The FDA issued a Cleared decision on February 27, 2002 after a review of 90 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K013946

510(k) Number K013946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2001
Decision Date February 27, 2002
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K013946.
MICROSULIS TISSUE ABLATION SYSTEM
K052919 · Microsulis Americas, Inc. · Jan 2006
GUIDANT MICROWAVE ABLATION SYSTEM
K041340 · Guidant Corporation, Cardiac Surgery · Jul 2004
VIVAWAVE MICROWAVE SYSTEM
K011676 · Vivant Medical, Inc. · Jun 2002
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
K003978 · Afx, Inc. · May 2001
K013946 · FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
Download PDF FDA Summary Afx, Inc.