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FDA 510(k)

LABYRINTH

K-Number: K211306 · 2021-06-24

ApplicantZavation Medical Products, LLC
Decision Date2021-06-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LABYRINTH is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211306. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABYRINTH?

LABYRINTH is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K211306.

When did LABYRINTH receive FDA 510(k) clearance?

LABYRINTH received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211306.

Who is the listed applicant for LABYRINTH?

The FDA 510(k) record lists Zavation Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABYRINTH?

The FDA product code for LABYRINTH is MAX.

Other records listing Zavation Medical Products, LLC 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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