FDA 510(k)

Exsalta

K-Number: K221676 · 2022-09-16

Decision Date2022-09-16

Product CodeBTA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Exsalta is a medical device manufactured by Drw Medical. It received FDA 510(k) clearance on 2022-09-16 under approval number K221676. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exsalta?

Exsalta is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Drw Medical. The 510(k) number is K221676.

When was Exsalta approved by the FDA?

Exsalta received FDA 510(k) clearance on 2022-09-16, under approval number K221676.

What company makes Exsalta?

Exsalta is manufactured by Drw Medical.

What is the FDA product code for Exsalta?

The FDA product code for Exsalta is BTA.

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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.