Cleared Traditional

Medline ENFit Connectors

K151628 · Medline Industries, Inc. · Gastroenterology & Urology

Jul 2015

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K151628 is an FDA 510(k) clearance for the Medline ENFit Connectors, a Enteral Specific Transition Connectors (Class II — Special Controls, product code PIO), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 24, 2015, 37 days after receiving the submission on June 17, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K151628 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2015
Decision Date	July 24, 2015
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PIO — Enteral Specific Transition Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors.