510(k) K162356

Vesair Cystoscopic Sheath by Solace Therapeutics — Product Code KNY

K162356 is an FDA 510(k) premarket notification submitted by Solace Therapeutics for the device "Vesair Cystoscopic Sheath". The FDA issued a decision of Substantially Equivalent on March 2, 2017. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Solace Therapeutics has at least 3 other 510(k) clearances on record.