FDA 510(k)

Bead Block

K-Number: K150876 · 2016-03-07

Decision Date2016-03-07

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bead Block is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles UK , Ltd.. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K150876. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bead Block?

Bead Block is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Biocompatibles UK , Ltd.. The 510(k) number is K150876.

When did Bead Block receive FDA 510(k) clearance?

Bead Block received FDA 510(k) clearance on 2016-03-07, under 510(k) number K150876.

Who is the listed applicant for Bead Block?

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

What is the FDA product code for Bead Block?

The FDA product code for Bead Block is KRD.

Other records listing Biocompatibles UK , Ltd. as applicant

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.

K162373LC Bead LUMI

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Official Source

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