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FDA 510(k)

ACCELA SYSTEM

K-Number: K081578 · 2008-06-20

ApplicantGenesis Biosystems, Inc.
Decision Date2008-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCELA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Biosystems, Inc.. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K081578. 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 ACCELA SYSTEM?

ACCELA SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Genesis Biosystems, Inc.. The 510(k) number is K081578.

When did ACCELA SYSTEM receive FDA 510(k) clearance?

ACCELA SYSTEM received FDA 510(k) clearance on 2008-06-20, under 510(k) number K081578.

Who is the listed applicant for ACCELA SYSTEM?

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

What is the FDA product code for ACCELA SYSTEM?

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

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Other records listing Genesis Biosystems, Inc. as applicant

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Related Devices (Code: GEX)

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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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