Vesair Cystoscopic Sheath
K-Number: K162356 · 2017-03-02
ApplicantSolace Therapeutics
Decision Date2017-03-02
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Vesair Cystoscopic Sheath is a medical device manufactured by Solace Therapeutics. It received FDA 510(k) clearance on 2017-03-02 under approval number K162356. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vesair Cystoscopic Sheath?
Vesair Cystoscopic Sheath is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Solace Therapeutics. The 510(k) number is K162356.
When was Vesair Cystoscopic Sheath approved by the FDA?
Vesair Cystoscopic Sheath received FDA 510(k) clearance on 2017-03-02, under approval number K162356.
What company makes Vesair Cystoscopic Sheath?
Vesair Cystoscopic Sheath is manufactured by Solace Therapeutics.
What is the FDA product code for Vesair Cystoscopic Sheath?
The FDA product code for Vesair Cystoscopic Sheath is KNY.
Related Devices (Code: KNY)
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.