Cleared Traditional

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

K190923 · Cardinalhealth · Gastroenterology & Urology
Nov 2019
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K190923 is an FDA 510(k) clearance for the Salem Sump Dual Lumen Stomach Tube with ENFit Connection, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Cardinalhealth (Mansfield, US). The FDA issued a Cleared decision on November 7, 2019, 212 days after receiving the submission on April 9, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K190923 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2019
Decision Date November 07, 2019
Days to Decision 212 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.

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