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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-11-17 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K173355.

When did Gastric Sizing Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Gastric Sizing Balloon Catheter?

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

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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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.

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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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