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FDA 510(k)

Venus Silk.expert

K-Number: K170734 · 2017-05-08

ApplicantCyden Limited
Decision Date2017-05-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Silk.expert is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170734. 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 Venus Silk.expert?

Venus Silk.expert is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Cyden Limited. The 510(k) number is K170734.

When did Venus Silk.expert receive FDA 510(k) clearance?

Venus Silk.expert received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170734.

Who is the listed applicant for Venus Silk.expert?

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

What is the FDA product code for Venus Silk.expert?

The FDA product code for Venus Silk.expert is GEX. This falls under the Gastroenterology category.

Other records listing Cyden Limited as applicant

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Related Devices (Code: GEX)

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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.

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