FDA 510(k)

DuraLazeTM HoLEP Laser Fiber

Numéro K : K153124 · 2016-07-26

Date de décision2016-07-26

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

DuraLazeTM HoLEP Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Medkey, LLC. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K153124. 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.

Questions fréquentes

What is the DuraLazeTM HoLEP Laser Fiber?

DuraLazeTM HoLEP Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Medkey, LLC. The 510(k) number is K153124.

When did DuraLazeTM HoLEP Laser Fiber receive FDA 510(k) clearance?

DuraLazeTM HoLEP Laser Fiber received FDA 510(k) clearance on 2016-07-26, under 510(k) number K153124.

Who is the listed applicant for DuraLazeTM HoLEP Laser Fiber?

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

What is the FDA product code for DuraLazeTM HoLEP Laser Fiber?

The FDA product code for DuraLazeTM HoLEP Laser Fiber is GEX. This falls under the Gastroenterology category.

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Source officielle

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