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FDA 510(k)

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

K-Number: K260783 · 2026-03-11

ApplicantKulzer, LLC
Decision Date2026-03-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is a medical device manufactured by Kulzer, LLC. It received FDA 510(k) clearance on 2026-03-11 under approval number K260783. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is a medical device that received FDA 510(k) clearance on 2026-03-11. It is manufactured by Kulzer, LLC. The 510(k) number is K260783.

When was Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One approved by the FDA?

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One received FDA 510(k) clearance on 2026-03-11, under approval number K260783.

What company makes Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is manufactured by Kulzer, LLC.

What is the FDA product code for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

The FDA product code for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One is EBF.

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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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