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FDA 510(k)

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port

K-Number: K180622 · 2018-10-23

ApplicantCovidien
Decision Date2018-10-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K180622. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port?

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Covidien. The 510(k) number is K180622.

When did Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port receive FDA 510(k) clearance?

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port received FDA 510(k) clearance on 2018-10-23, under 510(k) number K180622.

Who is the listed applicant for Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port?

The FDA product code for Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port is KNT.

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.

Other records listing Covidien 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.

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Related Devices (Code: KNT)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.