Cleared Special

Vesair Cystoscopic Sheath

K162356 · Solace Therapeutics · Gastroenterology & Urology
Mar 2017
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K162356 is an FDA 510(k) clearance for the Vesair Cystoscopic Sheath, a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY), submitted by Solace Therapeutics (Farmingham, US). The FDA issued a Cleared decision on March 2, 2017, 191 days after receiving the submission on August 23, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K162356 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2016
Decision Date March 02, 2017
Days to Decision 191 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNY — Accessories, Catheter, G-u
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130