Cleared Traditional

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection

K213174 · Cardinalhealth · Gastroenterology & Urology
May 2022
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K213174 is an FDA 510(k) clearance for the Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on May 19, 2022, 233 days after receiving the submission on September 28, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K213174 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date May 19, 2022
Days to Decision 233 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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