Joule System
K-Number: K182173 · 2019-03-06
ApplicantSciton, Inc
Decision Date2019-03-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Joule System is a medical device manufactured by Sciton, Inc. It received FDA 510(k) clearance on 2019-03-06 under approval number K182173. 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 Joule System?
Joule System is a medical device that received FDA 510(k) clearance on 2019-03-06. It is manufactured by Sciton, Inc. The 510(k) number is K182173.
When was Joule System approved by the FDA?
Joule System received FDA 510(k) clearance on 2019-03-06, under approval number K182173.
What company makes Joule System?
Joule System is manufactured by Sciton, Inc.
What is the FDA product code for Joule System?
The FDA product code for Joule System 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.