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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Reveallux, Corp. It received FDA 510(k) clearance on 2019-11-01 under 510(k) 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. The listed applicant is Reveallux, Corp. The 510(k) number is K191693.

When did BC-5 receive FDA 510(k) clearance?

BC-5 received FDA 510(k) clearance on 2019-11-01, under 510(k) number K191693.

Who is the listed applicant for BC-5?

The FDA 510(k) record lists Reveallux, Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-5?

The FDA product code for BC-5 is GEX. This falls under the Gastroenterology category.

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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