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FDA 510(k)

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

K-Number: K171347 · 2017-06-06

ApplicantXeridiem Medical Devices
Decision Date2017-06-06
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is a medical device manufactured by Xeridiem Medical Devices. It received FDA 510(k) clearance on 2017-06-06 under approval number K171347. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection?

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is a medical device that received FDA 510(k) clearance on 2017-06-06. It is manufactured by Xeridiem Medical Devices. The 510(k) number is K171347.

When was Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection approved by the FDA?

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection received FDA 510(k) clearance on 2017-06-06, under approval number K171347.

What company makes Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection?

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is manufactured by Xeridiem Medical Devices.

What is the FDA product code for Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection?

The FDA product code for Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is PIF.

Related Clinical Trials

NCT06691893 Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT06328985 Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients COMPLETED

Related Devices (Code: PIF)

K160642Medline ENFit SyringeMedline Industries, Inc. K161003EndoVive 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 ConnectorBoston Scientific Corporation K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEGbuk Enteral Limited K170162Vesco Medical Nasoenteric Feeding TubesVesco Medical, LLC K170555U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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