Sparkling
K-Number: K163655 · 2017-03-17
Decision Date2017-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sparkling is a medical device manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2017-03-17 under approval number K163655. 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 Sparkling?
Sparkling is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K163655.
When was Sparkling approved by the FDA?
Sparkling received FDA 510(k) clearance on 2017-03-17, under approval number K163655.
What company makes Sparkling?
Sparkling is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.
What is the FDA product code for Sparkling?
The FDA product code for Sparkling 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.