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FDA 510(k)

EluPro Antibiotic-Eluting BioEnvelope

K-Number: K262406 · 2026-08-12

ApplicantBoston Scientific
Decision Date2026-08-12
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EluPro Antibiotic-Eluting BioEnvelope is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K262406. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EluPro Antibiotic-Eluting BioEnvelope?

EluPro Antibiotic-Eluting BioEnvelope is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Boston Scientific. The 510(k) number is K262406.

When did EluPro Antibiotic-Eluting BioEnvelope receive FDA 510(k) clearance?

EluPro Antibiotic-Eluting BioEnvelope received FDA 510(k) clearance on 2026-08-12, under 510(k) number K262406.

Who is the listed applicant for EluPro Antibiotic-Eluting BioEnvelope?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EluPro Antibiotic-Eluting BioEnvelope?

The FDA product code for EluPro Antibiotic-Eluting BioEnvelope is FTM.

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Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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