SpassageQ
K-Number: K230386 · 2023-06-15
ApplicantSpass, Inc.
Decision Date2023-06-15
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SpassageQ is a medical device manufactured by Spass, Inc.. It received FDA 510(k) clearance on 2023-06-15 under approval number K230386. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpassageQ?
SpassageQ is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Spass, Inc.. The 510(k) number is K230386.
When was SpassageQ approved by the FDA?
SpassageQ received FDA 510(k) clearance on 2023-06-15, under approval number K230386.
What company makes SpassageQ?
SpassageQ is manufactured by Spass, Inc..
What is the FDA product code for SpassageQ?
The FDA product code for SpassageQ is PLB.
Related Devices (Code: PLB)
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.