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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 the device name listed in this FDA 510(k) record. The listed applicant is Kerecis. It received FDA 510(k) clearance on 2022-09-30 under 510(k) 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. The listed applicant is Kerecis. The 510(k) number is K213904.

When did Kerecis Oral receive FDA 510(k) clearance?

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

Who is the listed applicant for Kerecis Oral?

The FDA 510(k) record lists Kerecis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kerecis Oral?

The FDA product code for Kerecis Oral is NPL.

Other records listing Kerecis as applicant

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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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