Cleared Traditional

K171358 - Emprint SX Ablation Platform and Access...

K171358 is an FDA 510(k) clearance for Emprint SX Ablation Platform and Access..., manufactured by Coviden, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K171358 · Coviden, LLC · General & Plastic Surgery device
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Sep 2017
Decision
115d
Days
Class 2
Risk

K171358 is an FDA 510(k) clearance for the Emprint SX Ablation Platform and Accessories. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Coviden, LLC (Boulder, US). The FDA issued a Cleared decision on September 1, 2017 after a review of 115 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 Coviden, LLC devices

FDA 510(k) Submission Details - K171358

510(k) Number K171358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date September 01, 2017
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
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 K171358.
Certus 140 2.45GHz Ablation System
K173756 · Neuwave Medical, Inc. · Oct 2018
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
Emprint Ablation System
K163105 · Covidien, LLC · Dec 2016
EMPRINT ABLATION SYSTEM
K133821 · Covidien, LLC · Apr 2014