Cleared Traditional

K161003 - EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

K161003 is an FDA 510(k) clearance for EndoVive One Step Button Low Profile In..., manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K161003 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
67d
Days
Class 2
Risk

K161003 is an FDA 510(k) clearance for the EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Con.... Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on June 17, 2016 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K161003

510(k) Number K161003 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 11, 2016
Decision Date June 17, 2016
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 131d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIF Device Classification - Class 2, Special Controls

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 50
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K161003.
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K163586 · Trovrx, Inc. Dba Trovita Health Science · Mar 2017
Edi Catheter ENFit
K153688 · Maquet Critical Care AB · Mar 2017
Medline ENFit Syringe
K160642 · Medline Industries, Inc. · Nov 2016
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
K151503 · Gbuk Enteral Limited · Apr 2016
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711 · Covidien · Oct 2015
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
K150084 · Covidien · Jul 2015