AirSeal
K-Number: K190303 · 2019-03-28
ApplicantConmed Corporation
Decision Date2019-03-28
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
AirSeal is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2019-03-28 under approval number K190303. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AirSeal?
AirSeal is a medical device that received FDA 510(k) clearance on 2019-03-28. It is manufactured by Conmed Corporation. The 510(k) number is K190303.
When was AirSeal approved by the FDA?
AirSeal received FDA 510(k) clearance on 2019-03-28, under approval number K190303.
What company makes AirSeal?
AirSeal is manufactured by Conmed Corporation.
What is the FDA product code for AirSeal?
The FDA product code for AirSeal is HIF.
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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.