Quanta System Surgical Laser fibers
K-Number: K160513 · 2016-03-18
ApplicantQuanta System Spa
Decision Date2016-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Quanta System Surgical Laser fibers is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2016-03-18 under approval number K160513. 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 Quanta System Surgical Laser fibers?
Quanta System Surgical Laser fibers is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Quanta System Spa. The 510(k) number is K160513.
When was Quanta System Surgical Laser fibers approved by the FDA?
Quanta System Surgical Laser fibers received FDA 510(k) clearance on 2016-03-18, under approval number K160513.
What company makes Quanta System Surgical Laser fibers?
Quanta System Surgical Laser fibers is manufactured by Quanta System Spa.
What is the FDA product code for Quanta System Surgical Laser fibers?
The FDA product code for Quanta System Surgical Laser fibers is GEX. This falls under the Gastroenterology category.
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Official Source
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