Cleared Special

Entuit Nasal Jejunal Feeding Tube

K201322 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology
Jun 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K201322 is an FDA 510(k) clearance for the Entuit Nasal Jejunal Feeding Tube, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on June 17, 2020, 30 days after receiving the submission on May 18, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K201322 FDA.gov
FDA Decision Cleared SESK
Date Received May 18, 2020
Decision Date June 17, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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