Cleared Traditional

NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps

K152857 · Neomed, Inc. · Gastroenterology & Urology
Dec 2015
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K152857 is an FDA 510(k) clearance for the NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, 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 December 17, 2015, 78 days after receiving the submission on September 30, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K152857 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date December 17, 2015
Days to Decision 78 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.

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