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 a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2021-06-24 under approval 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. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K211306.
When was LABYRINTH approved by the FDA?
LABYRINTH received FDA 510(k) clearance on 2021-06-24, under approval number K211306.
What company makes LABYRINTH?
LABYRINTH is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for LABYRINTH?
The FDA product code for LABYRINTH is MAX.
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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.