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FDA 510(k)

U Deliver Bolink ENFit Enteral Feeding Sets

K-Number: K190310 · 2019-05-31

ApplicantU Deliver Medical, LLC
Decision Date2019-05-31
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

U Deliver Bolink ENFit Enteral Feeding Sets is a medical device manufactured by U Deliver Medical, LLC. It received FDA 510(k) clearance on 2019-05-31 under approval number K190310. 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 U Deliver Bolink ENFit Enteral Feeding Sets?

U Deliver Bolink ENFit Enteral Feeding Sets is a medical device that received FDA 510(k) clearance on 2019-05-31. It is manufactured by U Deliver Medical, LLC. The 510(k) number is K190310.

When was U Deliver Bolink ENFit Enteral Feeding Sets approved by the FDA?

U Deliver Bolink ENFit Enteral Feeding Sets received FDA 510(k) clearance on 2019-05-31, under approval number K190310.

What company makes U Deliver Bolink ENFit Enteral Feeding Sets?

U Deliver Bolink ENFit Enteral Feeding Sets is manufactured by U Deliver Medical, LLC.

What is the FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets?

The FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets is PIF.

Related Clinical Trials

NCT06328894 Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients COMPLETED NCT06328985 Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients COMPLETED NCT01536782 Optimal Tube Feeding Method in Head and Neck Cancer Patients WITHDRAWN

Other Devices by U Deliver Medical, LLC

K170555U Deliver Bolink ENFit Enteral Feeding Sets

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 K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionXeridiem Medical Devices

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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