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FDA 510(k)

Extension Feeding Set with ENFit™ Connectors

K-Number: K250481 · 2025-04-18

ApplicantSKY Medical, a.s.
Decision Date2025-04-18
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Extension Feeding Set with ENFit™ Connectors is the device name listed in this FDA 510(k) record. The listed applicant is SKY Medical, a.s.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250481. 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 Extension Feeding Set with ENFit™ Connectors?

Extension Feeding Set with ENFit™ Connectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is SKY Medical, a.s.. The 510(k) number is K250481.

When did Extension Feeding Set with ENFit™ Connectors receive FDA 510(k) clearance?

Extension Feeding Set with ENFit™ Connectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250481.

Who is the listed applicant for Extension Feeding Set with ENFit™ Connectors?

The FDA 510(k) record lists SKY Medical, a.s. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extension Feeding Set with ENFit™ Connectors?

The FDA product code for Extension Feeding Set with ENFit™ Connectors is PIF.

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.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco MedicalK232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT ConnectionXeridiem Medical Devices, A Spectrum Plastics Group Company

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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