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FDA 510(k)

585

K-Number: K172198 · 2017-10-17

ApplicantQuanta System Spa
Decision Date2017-10-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

585 is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K172198. 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 585?

585 is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Quanta System Spa. The 510(k) number is K172198.

When did 585 receive FDA 510(k) clearance?

585 received FDA 510(k) clearance on 2017-10-17, under 510(k) number K172198.

Who is the listed applicant for 585?

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

What is the FDA product code for 585?

The FDA product code for 585 is GEX. This falls under the Gastroenterology category.

Other records listing Quanta System Spa as applicant

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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

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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