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FDA 510(k)

Litho

K-Number: K163009 · 2016-12-01

ApplicantQuanta System Spa
Decision Date2016-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Litho 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 2016-12-01 under 510(k) number K163009. 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 Litho?

Litho is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Quanta System Spa. The 510(k) number is K163009.

When did Litho receive FDA 510(k) clearance?

Litho received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163009.

Who is the listed applicant for Litho?

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 Litho?

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

Other records listing Quanta System Spa 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.

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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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