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FDA 510(k)

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

K-Number: K180708 · 2018-10-18

ApplicantXeridiem Medical Devices, A Spectrum Plastics Group Company
Decision Date2018-10-18
Product CodePIF
Advisory CommitteeGU
DecisionUnknown

Device Summary

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit is a medical device manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company. It received FDA 510(k) clearance on 2018-10-18 under approval number K180708. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit?

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K180708.

When was Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit approved by the FDA?

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit received FDA 510(k) clearance on 2018-10-18, under approval number K180708.

What company makes Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit?

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit is manufactured by Xeridiem Medical Devices, A Spectrum Plastics Group Company.

What is the FDA product code for Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit?

The FDA product code for Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit is PIF.

Related Clinical Trials

NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT07599202 Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances ACTIVE_NOT_RECRUITING NCT07376837 Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study RECRUITING NCT07586072 Non-Randomized Trial of Bruxism-Related TMD Treatments COMPLETED

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Xeridiem Medical Devices, A Spectrum Plastics Group Company

K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

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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