Cleared Traditional

K133821 - EMPRINT ABLATION SYSTEM

K133821 is the FDA 510(k) clearance for EMPRINT ABLATION SYSTEM by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code NEY) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K133821 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
133d
Days
Class 2
Risk

K133821 is an FDA 510(k) clearance for the EMPRINT ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on April 28, 2014 after a review of 133 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 Covidien, LLC devices

Submission Details

510(k) Number K133821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date April 28, 2014
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 39
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K133821.
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
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006