BC-5
K-Number: K191693 · 2019-11-01
ApplicantReveallux, Corp
Decision Date2019-11-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BC-5 is a medical device manufactured by Reveallux, Corp. It received FDA 510(k) clearance on 2019-11-01 under approval number K191693. 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 BC-5?
BC-5 is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Reveallux, Corp. The 510(k) number is K191693.
When was BC-5 approved by the FDA?
BC-5 received FDA 510(k) clearance on 2019-11-01, under approval number K191693.
What company makes BC-5?
BC-5 is manufactured by Reveallux, Corp.
What is the FDA product code for BC-5?
The FDA product code for BC-5 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.