Cleared Traditional

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

K161141 · Pentaferte Italia S.R.L. · Gastroenterology & Urology

Mar 2017

Decision

334d

Days

Class 2

Risk

About This 510(k) Submission

K161141 is an FDA 510(k) clearance for the ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT, a Enteral Syringes With Enteral Specific Connectors (Class II — Special Controls, product code PNR), submitted by Pentaferte Italia S.R.L. (Campli, IT). The FDA issued a Cleared decision on March 22, 2017, 334 days after receiving the submission on April 22, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K161141 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2016
Decision Date	March 22, 2017
Days to Decision	334 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PNR — Enteral Syringes With Enteral Specific Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.