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FDA 510(k)

PROLITE III TOWER AND PR AND HR HANDPIECE

K-Number: K081095 · 2008-12-12

ApplicantQuantel S.A.
Decision Date2008-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLITE III TOWER AND PR AND HR HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Quantel S.A.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K081095. 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 PROLITE III TOWER AND PR AND HR HANDPIECE?

PROLITE III TOWER AND PR AND HR HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Quantel S.A.. The 510(k) number is K081095.

When did PROLITE III TOWER AND PR AND HR HANDPIECE receive FDA 510(k) clearance?

PROLITE III TOWER AND PR AND HR HANDPIECE received FDA 510(k) clearance on 2008-12-12, under 510(k) number K081095.

Who is the listed applicant for PROLITE III TOWER AND PR AND HR HANDPIECE?

The FDA 510(k) record lists Quantel S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLITE III TOWER AND PR AND HR HANDPIECE?

The FDA product code for PROLITE III TOWER AND PR AND HR HANDPIECE 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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