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FDA 510(k)

SPECTRAGENICS ATS-1

K-Number: K060567 · 2006-04-28

ApplicantSpectragenics, Inc.
Decision Date2006-04-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRAGENICS ATS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Spectragenics, Inc.. It received FDA 510(k) clearance on 2006-04-28 under 510(k) number K060567. 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 SPECTRAGENICS ATS-1?

SPECTRAGENICS ATS-1 is a medical device that received FDA 510(k) clearance on 2006-04-28. The listed applicant is Spectragenics, Inc.. The 510(k) number is K060567.

When did SPECTRAGENICS ATS-1 receive FDA 510(k) clearance?

SPECTRAGENICS ATS-1 received FDA 510(k) clearance on 2006-04-28, under 510(k) number K060567.

Who is the listed applicant for SPECTRAGENICS ATS-1?

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

What is the FDA product code for SPECTRAGENICS ATS-1?

The FDA product code for SPECTRAGENICS ATS-1 is GEX. This falls under the Gastroenterology category.

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Official Source

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