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FDA 510(k)

RIVOS™ EUS Access Device (M00553900)

K-Number: K260428 · 2026-06-17

ApplicantBoston Scientific Corporation
Decision Date2026-06-17
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RIVOS™ EUS Access Device (M00553900) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260428. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIVOS™ EUS Access Device (M00553900)?

RIVOS™ EUS Access Device (M00553900) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260428.

When did RIVOS™ EUS Access Device (M00553900) receive FDA 510(k) clearance?

RIVOS™ EUS Access Device (M00553900) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260428.

Who is the listed applicant for RIVOS™ EUS Access Device (M00553900)?

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

What is the FDA product code for RIVOS™ EUS Access Device (M00553900)?

The FDA product code for RIVOS™ EUS Access Device (M00553900) is ODG.

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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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