Cleared Traditional

K100744 - CERTUS 140 MICROWAVE ABLATION SYSTEM AN...

K100744 is an FDA 510(k) clearance for CERTUS 140 MICROWAVE ABLATION SYSTEM AN..., manufactured by Neuwave Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K100744 · Neuwave Medical, Inc. · General & Plastic Surgery device
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Oct 2010
Decision
220d
Days
Class 2
Risk

K100744 is an FDA 510(k) clearance for the CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Neuwave Medical, Inc. (Madision, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 220 days - an extended review 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: 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.

View all Neuwave Medical, Inc. devices

FDA 510(k) Submission Details - K100744

510(k) Number K100744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2010
Decision Date October 22, 2010
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 K100744.
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
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K061865 · Guidant Corp. · Jul 2006