Cleared Traditional

K053535 - VIVAWAVE MICROWAVE ABLATION SYSTEM

K053535 is an FDA 510(k) clearance for VIVAWAVE MICROWAVE ABLATION SYSTEM, manufactured by Valleylab. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K053535 · Valleylab · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
129d
Days
Class 2
Risk

K053535 is an FDA 510(k) clearance for the VIVAWAVE MICROWAVE ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Valleylab (Boulder, US). The FDA issued a Cleared decision on April 27, 2006 after a review of 129 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 - K053535

510(k) Number K053535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2005
Decision Date April 27, 2006
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
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 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K053535.
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K070356 · Medwaves Incorporated · Dec 2007
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
K070023 · Microsurgeon, Inc. · Aug 2007
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006
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
K053535 · VIVAWAVE MICROWAVE ABLATION SYSTEM
Download PDF FDA Summary Valleylab