FDA 510(k), K050503, SINGLE USE ASPIRATION NEEDLE NA-201SX-4022

FDA 510(k), K050503, SINGLE USE ASPIRATION NEEDLE NA-201SX-4022

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510(K) Number: K050503
Device Name: SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
Manufacturer: LARUA STORMS-TYLER
Device Classification Name: Biopsy Needle
Regulation Number: FCG
Classification Product Code: KXA
Date Received: 02/28/2005
Decision Date: 05/12/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • 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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