FDA 510(k)

ELLAVI UBT

K-Number: K230849 · 2023-11-13

Decision Date2023-11-13

Product CodeOQY

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ELLAVI UBT is the device name listed in this FDA 510(k) record. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K230849. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLAVI UBT?

ELLAVI UBT is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Sinapi Biomedical (Pty) , Ltd.. The 510(k) number is K230849.

When did ELLAVI UBT receive FDA 510(k) clearance?

ELLAVI UBT received FDA 510(k) clearance on 2023-11-13, under 510(k) number K230849.

Who is the listed applicant for ELLAVI UBT?

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

What is the FDA product code for ELLAVI UBT?

The FDA product code for ELLAVI UBT is OQY.

Related Devices (Code: OQY)

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.

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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.