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FDA 510(k)

Gastric Sizing Balloon Catheter

K-Number: K173355 · 2017-11-17

ApplicantCook Incorporated
Decision Date2017-11-17
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

Gastric Sizing Balloon Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-11-17 under approval number K173355. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Gastric Sizing Balloon Catheter?

Gastric Sizing Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Cook Incorporated. The 510(k) number is K173355.

When was Gastric Sizing Balloon Catheter approved by the FDA?

Gastric Sizing Balloon Catheter received FDA 510(k) clearance on 2017-11-17, under approval number K173355.

What company makes Gastric Sizing Balloon Catheter?

Gastric Sizing Balloon Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Gastric Sizing Balloon Catheter?

The FDA product code for Gastric Sizing Balloon Catheter is KNT.

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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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