Clearance Summary
Vesair Cystoscopic Sheath received FDA 510(k) clearance under submission number K162356, sponsored by Solace Therapeutics. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-03-02.
- Submission: K162356
- Applicant / Sponsor: Solace Therapeutics
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2017-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KNY and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.