Cleared Special

K172742 - AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

K172742 is an FDA 510(k) clearance for AtriClip LAA Exclusion System with prel..., manufactured by AtriCure, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 29-day FDA review.

K172742 · AtriCure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
29d
Days
Class 2
Risk

K172742 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2). Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on October 11, 2017 after a review of 29 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172742

510(k) Number K172742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date October 11, 2017
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FZP Device Classification - Class 2, Special Controls

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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K172742.
AnastoClip GC Closure System
K173323 · LeMaitre Vascular, Inc. · Mar 2018
AtriClip FLEX-V
K180010 · AtriCure, Inc. · Jan 2018
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · AtriCure, Inc. · Oct 2017
Amsel Occluder Device
K172479 · Amsel Medical · Sep 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
K163261 · AtriCure, Inc. · May 2017
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · Teleflex Medical · Sep 2016
K172742 · AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
Download PDF FDA Summary AtriCure, Inc.