Cleared Special

K231505 - GORE ACUSEAL Vascular Graft

K231505 is the FDA 510(k) clearance for GORE ACUSEAL Vascular Graft by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Special 510(k) pathway after a 30-day FDA review.

K231505 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Jun 2023
Decision
30d
Days
Class 2
Risk

K231505 is an FDA 510(k) clearance for the GORE® ACUSEAL Vascular Graft. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 23, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K231505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2023
Decision Date June 23, 2023
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 92
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K231505.
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K233783 · Peca Labs, Inc. · Jan 2024
GORE® PROPATEN® Vascular Graft
K232312 · W.L. Gore & Associates, Inc. · Jan 2024
GORE® ACUSEAL Vascular Graft
K233551 · W.L. Gore & Associates, Inc. · Dec 2023
HeRO Graft
K213845 · Merit Medical Systems, Inc. · Aug 2022
exGraft, exGraft Carbon
K221628 · Peca Labs · Aug 2022
HeRO Graft, HeRO Adapter
K203724 · Merit Medical Systems, Inc. · May 2021