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FDA 510(k)

LYOPLANT ONLAY

K-Number: K122791 · 2013-06-04

ApplicantAesculap, Inc.
Decision Date2013-06-04
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LYOPLANT ONLAY is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2013-06-04 under 510(k) number K122791. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYOPLANT ONLAY?

LYOPLANT ONLAY is a medical device that received FDA 510(k) clearance on 2013-06-04. The listed applicant is Aesculap, Inc.. The 510(k) number is K122791.

When did LYOPLANT ONLAY receive FDA 510(k) clearance?

LYOPLANT ONLAY received FDA 510(k) clearance on 2013-06-04, under 510(k) number K122791.

Who is the listed applicant for LYOPLANT ONLAY?

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

What is the FDA product code for LYOPLANT ONLAY?

The FDA product code for LYOPLANT ONLAY is GXQ.

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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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