Cleared Traditional

Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

K181787 · Cedic S.R.L. · Gastroenterology & Urology

Apr 2019

Decision

294d

Days

Class 2

Risk

About This 510(k) Submission

K181787 is an FDA 510(k) clearance for the Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on April 25, 2019, 294 days after receiving the submission on July 5, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K181787 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2018
Decision Date	April 25, 2019
Days to Decision	294 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.