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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 a medical device manufactured by SKY Medical, a.s.. It received FDA 510(k) clearance on 2025-04-18 under approval 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. It is manufactured by SKY Medical, a.s.. The 510(k) number is K250481.

When was Extension Feeding Set with ENFit™ Connectors approved by the FDA?

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

What company makes Extension Feeding Set with ENFit™ Connectors?

Extension Feeding Set with ENFit™ Connectors is manufactured by SKY Medical, a.s..

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)

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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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