FDA 510(k)

Cook Holmium Laser Fiber

K-Number: K163197 · 2017-05-24

Decision Date2017-05-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cook Holmium Laser Fiber is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-05-24 under approval number K163197. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cook Holmium Laser Fiber?

Cook Holmium Laser Fiber is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Cook Incorporated. The 510(k) number is K163197.

When was Cook Holmium Laser Fiber approved by the FDA?

Cook Holmium Laser Fiber received FDA 510(k) clearance on 2017-05-24, under approval number K163197.

What company makes Cook Holmium Laser Fiber?

Cook Holmium Laser Fiber is manufactured by Cook Incorporated.

What is the FDA product code for Cook Holmium Laser Fiber?

The FDA product code for Cook Holmium Laser Fiber is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.