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FDA 510(k)

Uresta®

K-Number: K233548 · 2024-04-03

ApplicantResilia, Inc.
Decision Date2024-04-03
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Uresta® is a medical device manufactured by Resilia, Inc.. It received FDA 510(k) clearance on 2024-04-03 under approval number K233548. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Uresta®?

Uresta® is a medical device that received FDA 510(k) clearance on 2024-04-03. It is manufactured by Resilia, Inc.. The 510(k) number is K233548.

When was Uresta® approved by the FDA?

Uresta® received FDA 510(k) clearance on 2024-04-03, under approval number K233548.

What company makes Uresta®?

Uresta® is manufactured by Resilia, Inc..

What is the FDA product code for Uresta®?

The FDA product code for Uresta® is HHW.

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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.

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