Cleared Special

K131803 - GUARDIAN URETHRAL SHEATH

K131803 is an FDA 510(k) clearance for GUARDIAN URETHRAL SHEATH, manufactured by Solace Therapeutics. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Special 510(k) pathway after a 62-day FDA review.

K131803 · Solace Therapeutics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
62d
Days
Class 2
Risk

K131803 is an FDA 510(k) clearance for the GUARDIAN URETHRAL 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 August 20, 2013 after a review of 62 days - a notably fast clearance 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K131803

510(k) Number K131803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2013
Decision Date August 20, 2013
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

KNY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K131803.
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