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FDA 510(k), K173087, UroLift System (UL400 and UL500)
FDA 510(k), K173087, UroLift System (UL400 and UL500)
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510(K) Number: K173087
Device Name: UroLift System (UL400 and UL500)
Manufacturer: Louis-Pierre Marcoux
Device Classification Name: Implantable Transprostatic Tissue Retractor System
Regulation Number: PEW
Classification Product Code: KXA
Date Received: 09/29/2017
Decision Date: 12/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: UroLift System (UL400 and UL500)
Manufacturer: Louis-Pierre Marcoux
Device Classification Name: Implantable Transprostatic Tissue Retractor System
Regulation Number: PEW
Classification Product Code: KXA
Date Received: 09/29/2017
Decision Date: 12/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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