Cleared Special

GUARDIAN URETHRAL SHEATH

K141252 · Solace Therapeutics · Gastroenterology & Urology
Jun 2014
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K141252 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 June 9, 2014, 26 days after receiving the submission on May 14, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K141252 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2014
Decision Date June 09, 2014
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

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