Cleared Traditional

K133821 - EMPRINT ABLATION SYSTEM

K133821 is an FDA 510(k) clearance for EMPRINT ABLATION SYSTEM, manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K133821

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.

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 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K133821.
Certus 140 2.45GHz Ablation System
K160936 · Neuwave Medical, Inc. · May 2016
AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
K143203 · Medwaves Incorporated · Aug 2015
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K141785 · Bsd Medical Corp. · Mar 2015
CERTUS 140 CERTUSURGGT SURGICAL TOOL
K130399 · Neuwave Medical, Inc. · Jul 2013
CERTUS 140 2.45GHZ ABLATION SYSTEM
K122217 · Neuwave Medical, Inc. · Dec 2012
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
K122762 · Microsulis Medical Limited · Nov 2012
K133821 · EMPRINT ABLATION SYSTEM
Download PDF FDA Summary Covidien, LLC