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FDA 510(k)

Stomach Tube

K-Number: K162340 · 2017-10-11

ApplicantWell Lead Medical Co., Ltd.
Decision Date2017-10-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stomach Tube is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-10-11 under approval number K162340. 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 Stomach Tube?

Stomach Tube is a medical device that received FDA 510(k) clearance on 2017-10-11. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K162340.

When was Stomach Tube approved by the FDA?

Stomach Tube received FDA 510(k) clearance on 2017-10-11, under approval number K162340.

What company makes Stomach Tube?

Stomach Tube is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Stomach Tube?

The FDA product code for Stomach Tube is KNT.

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K151084Well Lead Ureteral Access Sheath K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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Related Devices (Code: 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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