Cleared Traditional

EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector

K150679 · Boston Scientific Corp · Gastroenterology & Urology

May 2015

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K150679 is an FDA 510(k) clearance for the EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Boston Scientific Corp (Marlborough, US). The FDA issued a Cleared decision on May 29, 2015, 73 days after receiving the submission on March 17, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K150679 FDA.gov
FDA Decision	Cleared SEKD
Date Received	March 17, 2015
Decision Date	May 29, 2015
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	To Facilitate Enteral Specific Connections.