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FDA 510(k)

Kerecis Oral

K-Number: K213904 · 2022-09-30

ApplicantKerecis
Decision Date2022-09-30
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Kerecis Oral is a medical device manufactured by Kerecis. It received FDA 510(k) clearance on 2022-09-30 under approval number K213904. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kerecis Oral?

Kerecis Oral is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Kerecis. The 510(k) number is K213904.

When was Kerecis Oral approved by the FDA?

Kerecis Oral received FDA 510(k) clearance on 2022-09-30, under approval number K213904.

What company makes Kerecis Oral?

Kerecis Oral is manufactured by Kerecis.

What is the FDA product code for Kerecis Oral?

The FDA product code for Kerecis Oral is NPL.

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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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