Cleared Special

K262406 - EluPro Antibiotic-Eluting BioEnvelope

K262406 is an FDA 510(k) clearance for EluPro Antibiotic-Eluting BioEnvelope, manufactured by Boston Scientific. The device is a Class 2 Cardiovascular device with product code FTM cleared through the Special 510(k) pathway after a 28-day FDA review.

K262406 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
28d
Days
Class 2
Risk

K262406 is an FDA 510(k) clearance for the EluPro Antibiotic-Eluting BioEnvelope. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Boston Scientific (Saint Paul, US). The FDA issued a Cleared decision on August 12, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.3300 - 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.

FDA 510(k) Submission Details - K262406

510(k) Number K262406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2026
Decision Date August 12, 2026
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTM Mesh, Surgical

All 163
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K262406.
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K262406 · EluPro Antibiotic-Eluting BioEnvelope
Download PDF FDA Summary Boston Scientific