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FDA 510(k)

Cook Holmium Laser Fiber

K-Number: K163197 · 2017-05-24

ApplicantCook Incorporated
Decision Date2017-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cook Holmium Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-05-24 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K163197.

When did Cook Holmium Laser Fiber receive FDA 510(k) clearance?

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

Who is the listed applicant for Cook Holmium Laser Fiber?

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 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

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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