EluPro Antibiotic-Eluting BioEnvelope
FDA 510(k) K262406 · Boston Scientific
510(k) numberK262406
Submission
- Device name
- EluPro Antibiotic-Eluting BioEnvelope
- Applicant
- Boston Scientific
Saint Paul, MN, US - Received
- July 15, 2026
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was EluPro Antibiotic-Eluting BioEnvelope cleared by the FDA?
EluPro Antibiotic-Eluting BioEnvelope (K262406) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 28 days after the submission was received.
What is the product code of K262406?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.