Laser Ureteral Catheter
K-Number: K181431 · 2018-07-30
ApplicantCook Incorporated
Decision Date2018-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Laser Ureteral Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-07-30 under approval number K181431. 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 Laser Ureteral Catheter?
Laser Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2018-07-30. It is manufactured by Cook Incorporated. The 510(k) number is K181431.
When was Laser Ureteral Catheter approved by the FDA?
Laser Ureteral Catheter received FDA 510(k) clearance on 2018-07-30, under approval number K181431.
What company makes Laser Ureteral Catheter?
Laser Ureteral Catheter is manufactured by Cook Incorporated.
What is the FDA product code for Laser Ureteral Catheter?
The FDA product code for Laser Ureteral Catheter 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.