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FDA 510(k)

EP Granules™ BVF

K-Number: K180853 · 2018-08-06

ApplicantElute, Inc.
Decision Date2018-08-06
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EP Granules™ BVF is the device name listed in this FDA 510(k) record. The listed applicant is Elute, Inc.. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K180853. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP Granules™ BVF?

EP Granules™ BVF is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Elute, Inc.. The 510(k) number is K180853.

When did EP Granules™ BVF receive FDA 510(k) clearance?

EP Granules™ BVF received FDA 510(k) clearance on 2018-08-06, under 510(k) number K180853.

Who is the listed applicant for EP Granules™ BVF?

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

What is the FDA product code for EP Granules™ BVF?

The FDA product code for EP Granules™ BVF is MQV.

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Other records listing Elute, Inc. as applicant

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Official Source

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