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FDA 510(k)

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)

K-Number: K160654 · 2016-05-04

ApplicantCovidien, LLC
Decision Date2016-05-04
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2016-05-04 under approval number K160654. 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 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)?

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Covidien, LLC. The 510(k) number is K160654.

When was GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) approved by the FDA?

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) received FDA 510(k) clearance on 2016-05-04, under approval number K160654.

What company makes GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)?

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) is manufactured by Covidien, LLC.

What is the FDA product code for GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)?

The FDA product code for GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) 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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