FDA 510(k)

MOSES Raydar™

K-Number: K260100 · 2026-05-18

Decision Date2026-05-18

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MOSES Raydar™ 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 2026-05-18 under 510(k) number K260100. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSES Raydar™?

MOSES Raydar™ is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260100.

When did MOSES Raydar™ receive FDA 510(k) clearance?

MOSES Raydar™ received FDA 510(k) clearance on 2026-05-18, under 510(k) number K260100.

Who is the listed applicant for MOSES Raydar™?

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 MOSES Raydar™?

The FDA product code for MOSES Raydar™ is GEX. This falls under the Gastroenterology category.

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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.