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FDA 510(k)

Rapid Family

K-Number: K173169 · 2017-11-20

ApplicantSharplight Technologies, Ltd.
Decision Date2017-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rapid Family is the device name listed in this FDA 510(k) record. The listed applicant is Sharplight Technologies, Ltd.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K173169. 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 Rapid Family?

Rapid Family is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Sharplight Technologies, Ltd.. The 510(k) number is K173169.

When did Rapid Family receive FDA 510(k) clearance?

Rapid Family received FDA 510(k) clearance on 2017-11-20, under 510(k) number K173169.

Who is the listed applicant for Rapid Family?

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

What is the FDA product code for Rapid Family?

The FDA product code for Rapid Family is GEX. This falls under the Gastroenterology category.

Other records listing Sharplight Technologies, Ltd. as applicant

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.

K233304Omnimax S3, Omnimax S4

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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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