Cleared Special

GUARDIAN URETHRAL SHEATH

K131803 · Solace Therapeutics · Gastroenterology & Urology
Aug 2013
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K131803 is an FDA 510(k) clearance for the GUARDIAN URETHRAL 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 August 20, 2013, 62 days after receiving the submission on June 19, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K131803 FDA.gov
FDA Decision Cleared 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

Device Classification

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