EluPro Antibiotic-Eluting BioEnvelope— 510(k) K262406

Name: FDA 510(k) clearance K262406
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

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.

Clearance details

Applicant: Boston Scientific
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2026-07-15
Decision date: 2026-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTM

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K250598 — Endoform Reconstructive Template - PLGA2025-06-03
K243595 — OviTex PRS (Long-Term Resorbable)2024-12-19
K233991 — CanGaroo RM Antibacterial Envelope2024-06-14
K241126 — OviTex PRS2024-05-22
K223052 — Peri-Guard and Supple Peri-Guard2023-04-07

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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, 2020-01-01 through 2026-04-23. 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.