Cleared Traditional

K070356 - MEDWAVES MICROWAVE COAGULATION/ABLATION...

K070356 is an FDA 510(k) clearance for MEDWAVES MICROWAVE COAGULATION/ABLATION..., manufactured by Medwaves Incorporated. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K070356 · Medwaves Incorporated · General & Plastic Surgery device
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Dec 2007
Decision
315d
Days
Class 2
Risk

K070356 is an FDA 510(k) clearance for the MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Medwaves Incorporated (San Diego, US). The FDA issued a Cleared decision on December 18, 2007 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Medwaves Incorporated devices

FDA 510(k) Submission Details - K070356

510(k) Number K070356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2007
Decision Date December 18, 2007
Days to Decision 315 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
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 40
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K070356.
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K061865 · Guidant Corp. · Jul 2006