Cleared Traditional

K163261 - AtriClip PRO

K163261 is the FDA 510(k) clearance for AtriClip PRO by AtriCure, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K163261 · AtriCure, Inc. · General & Plastic Surgery device
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May 2017
Decision
179d
Days
Class 2
Risk

K163261 is an FDA 510(k) clearance for the AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gil.... Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on May 19, 2017 after a review of 179 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 AtriCure, Inc. devices

Submission Details

510(k) Number K163261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date May 19, 2017
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K163261.
AtriClip FLEX-V
K180010 · AtriCure, Inc. · Jan 2018
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · AtriCure, Inc. · Oct 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · AtriCure, Inc. · Oct 2017
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · Teleflex Medical · Sep 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · AtriCure, Inc. · Mar 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · AtriCure, Inc. · Jan 2016