Cleared Special

K162356 - Vesair Cystoscopic Sheath (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162356 · Solace Therapeutics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
191d
Days
Class 2
Risk

K162356 is an FDA 510(k) clearance for the Vesair Cystoscopic Sheath. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Solace Therapeutics (Farmingham, US). The FDA issued a Cleared decision on March 2, 2017 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solace Therapeutics devices

Submission Details

510(k) Number K162356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.