DeviceClearance

EluPro Antibiotic-Eluting BioEnvelope— 510(k) K262406

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K262406 for EluPro Antibiotic-Eluting BioEnvelope, Substantially Equivalent on 2026-08-12. Applicant: Boston Scientific. Device class: 2.

Summary

Boston Scientific's EluPro Antibiotic-Eluting BioEnvelope is filed under product code FTM, surgical mesh. The record gives no model numbers or description beyond the name.

Class II, 21 CFR 878.3300. The Cardiovascular review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.

Boston Scientific filed from Saint Paul, Minnesota. The decision came 28 calendar days after receipt (July 15 to August 12, 2026), and it was substantially equivalent.

Clearance details

Applicant
Boston Scientific
Product code
Product code FTM
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Saint Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.