Cleared Traditional

CONMED IRRIGATION NOZZLE

K050992 · Conmedcorp · Gastroenterology & Urology
Jul 2005
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K050992 is an FDA 510(k) clearance for the CONMED IRRIGATION NOZZLE, a Colonic Irrigation System (Class II — Special Controls, product code KPL), submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on July 14, 2005, 86 days after receiving the submission on April 19, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5220.

Submission Details

510(k) Number K050992 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2005
Decision Date July 14, 2005
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPL — Colonic Irrigation System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5220

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