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FDA 510(k)

STARLIGHT, MODEL PD9012

K-Number: K073317 · 2008-09-03

ApplicantF.P. Rubinstein Y Cia S.R.L.
Decision Date2008-09-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STARLIGHT, MODEL PD9012 is the device name listed in this FDA 510(k) record. The listed applicant is F.P. Rubinstein Y Cia S.R.L.. It received FDA 510(k) clearance on 2008-09-03 under 510(k) number K073317. 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 STARLIGHT, MODEL PD9012?

STARLIGHT, MODEL PD9012 is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is F.P. Rubinstein Y Cia S.R.L.. The 510(k) number is K073317.

When did STARLIGHT, MODEL PD9012 receive FDA 510(k) clearance?

STARLIGHT, MODEL PD9012 received FDA 510(k) clearance on 2008-09-03, under 510(k) number K073317.

Who is the listed applicant for STARLIGHT, MODEL PD9012?

The FDA 510(k) record lists F.P. Rubinstein Y Cia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARLIGHT, MODEL PD9012?

The FDA product code for STARLIGHT, MODEL PD9012 is GEX. This falls under the Gastroenterology category.

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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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