SinuBand
K-Number: K160101 · 2016-07-27
Decision Date2016-07-27
Product CodeQJL
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
SinuBand is a medical device manufactured by Bioinspire Technologies, Incorporated. It received FDA 510(k) clearance on 2016-07-27 under approval number K160101. The device is classified under product code QJL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SinuBand?
SinuBand is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Bioinspire Technologies, Incorporated. The 510(k) number is K160101.
When was SinuBand approved by the FDA?
SinuBand received FDA 510(k) clearance on 2016-07-27, under approval number K160101.
What company makes SinuBand?
SinuBand is manufactured by Bioinspire Technologies, Incorporated.
What is the FDA product code for SinuBand?
The FDA product code for SinuBand is QJL.
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.