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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 the device name listed in this FDA 510(k) record. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. It received FDA 510(k) clearance on 2018-10-18 under 510(k) 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. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K180708.

When did 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 receive FDA 510(k) clearance?

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 510(k) number K180708.

Who is the listed applicant 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 510(k) record lists Xeridiem Medical Devices, A Spectrum Plastics Group Company as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05427929Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode DistanceACTIVE_NOT_RECRUITINGNCT06052891CHAMP For the Feeder: Tube Feeding StudyENROLLING_BY_INVITATIONNCT07669129The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported OutcomesNOT_YET_RECRUITINGNCT07696507Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back PainNOT_YET_RECRUITINGNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITINGNCT05966311Pediatric Percutaneous Ultrasound Gastrostomy TechniqueRECRUITING

Other records listing Xeridiem Medical Devices, A Spectrum Plastics Group Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

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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