Cleared Special

K232295 - LAA Exclusion System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232295 · Syntheon, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
29d
Days
Class 2
Risk

K232295 is an FDA 510(k) clearance for the LAA Exclusion System. Classified as Left Atrial Appendage Clip, Implantable (product code PZX), Class II - Special Controls.

Submitted by Syntheon, LLC (Miami, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4300 - the FDA cardiovascular device oversight 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.

View all Syntheon, LLC devices

Submission Details

510(k) Number K232295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2023
Decision Date August 30, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PZX Left Atrial Appendage Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition Intended To Occlude The Left Atrial Appendage.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - PZX Left Atrial Appendage Clip, Implantable

All 7
Devices cleared under the same product code (PZX) and FDA review panel - the closest regulatory comparables to K232295.
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · AtriCure, Inc. · Jan 2025
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · AtriCure, Inc. · Jul 2024
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · AtriCure, Inc. · Nov 2023
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · Syntheon · Oct 2022
AtriClip LAA Exclusion System
K210293 · AtriCure, Inc. · Mar 2021