Cleared Traditional

K093679 - ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0

K093679 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 Traditional 510(k) pathway after a 195-day FDA review.

K093679 · AtriCure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
195d
Days
Class 2
Risk

K093679 is an FDA 510(k) clearance for the ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV.... Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 10, 2010 after a review of 195 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.

FDA 510(k) Submission Details - K093679

510(k) Number K093679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date June 10, 2010
Days to Decision 195 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
80d slower than avg
Panel avg: 115d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 177
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K093679.
COLONRING
K093661 · Niti Surgical Solutions, Ltd. · Feb 2011
ENDOSCOPIC CLIP SYSTEM
K102081 · Aesculap, Inc. · Aug 2010
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
K101018 · Cardica, Inc. · Jun 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
K091987 · LeMaitre Vascular, Inc. · Apr 2010
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
K100242 · Surgical Devices, A Division of Tyco Healthcare · Feb 2010
IMPLANTABLE CLIP
K100090 · Genicon · Feb 2010
K093679 · ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
Download PDF FDA Summary AtriCure, Inc.