Cleared Traditional

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)

K183540 · Neomed, Inc. · Gastroenterology & Urology

Apr 2019

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K183540 is an FDA 510(k) clearance for the Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL), a Enteral Syringes With Enteral Specific Connectors (Class II — Special Controls, product code PNR), submitted by Neomed, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 30, 2019, 131 days after receiving the submission on December 20, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K183540 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2018
Decision Date	April 30, 2019
Days to Decision	131 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.