Cleared Traditional

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)

K161039 · Neomed, Inc. · Gastroenterology & Urology

Jun 2016

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K161039 is an FDA 510(k) clearance for the NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL), 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 June 17, 2016, 65 days after receiving the submission on April 13, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K161039 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2016
Decision Date	June 17, 2016
Days to Decision	65 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.