FDA 510(k)

Entuit Start Initial Placement Gastrostomy Set

K-Number: K170323 · 2017-09-14

Decision Date2017-09-14

Product CodeKGC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Entuit Start Initial Placement Gastrostomy Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-09-14 under approval number K170323. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Entuit Start Initial Placement Gastrostomy Set?

Entuit Start Initial Placement Gastrostomy Set is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Cook Incorporated. The 510(k) number is K170323.

When was Entuit Start Initial Placement Gastrostomy Set approved by the FDA?

Entuit Start Initial Placement Gastrostomy Set received FDA 510(k) clearance on 2017-09-14, under approval number K170323.

What company makes Entuit Start Initial Placement Gastrostomy Set?

Entuit Start Initial Placement Gastrostomy Set is manufactured by Cook Incorporated.

What is the FDA product code for Entuit Start Initial Placement Gastrostomy Set?

The FDA product code for Entuit Start Initial Placement Gastrostomy Set is KGC.

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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.