Cleared Traditional

K041340 - GUIDANT MICROWAVE ABLATION SYSTEM

K041340 is an FDA 510(k) clearance for GUIDANT MICROWAVE ABLATION SYSTEM, manufactured by Guidant Corporation, Cardiac Surgery. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K041340 · Guidant Corporation, Cardiac Surgery · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
69d
Days
Class 2
Risk

K041340 is an FDA 510(k) clearance for the GUIDANT MICROWAVE ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Guidant Corporation, Cardiac Surgery (Santa Clara, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041340

510(k) Number K041340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 28, 2004
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K041340.
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006
VIVAWAVE MICROWAVE ABLATION SYSTEM
K053535 · Valleylab · Apr 2006
MICROSULIS TISSUE ABLATION SYSTEM
K052919 · Microsulis Americas, Inc. · Jan 2006
VIVAWAVE MICROWAVE SYSTEM
K011676 · Vivant Medical, Inc. · Jun 2002
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
K013946 · Afx, Inc. · Feb 2002
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
K003978 · Afx, Inc. · May 2001

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K041340 · GUIDANT MICROWAVE ABLATION SYSTEM
Download PDF FDA Summary Guidant Corporation, …