Cleared Traditional

CERTUS 140 CERTUSURGGT SURGICAL TOOL (K130399) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130399 · Neuwave Medical, Inc. · General & Plastic Surgery device
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Jul 2013
Decision
149d
Days
Class 2
Risk

K130399 is an FDA 510(k) clearance for the CERTUS 140 CERTUSURGGT SURGICAL TOOL. 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 July 18, 2013 after a review of 149 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.

View all Neuwave Medical, Inc. devices

Submission Details

510(k) Number K130399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date July 18, 2013
Days to Decision 149 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
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K130399.
Swift System
K181941 · Emblation , Ltd. · Oct 2018
miraDry System
K180396 · Miramar Labs, Inc. · Mar 2018
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
K162449 · AngioDynamics, Inc. · May 2017