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510(k) K173659

Howell D.A.S.H Extraction Balloon with Multiple Sizing by Wilson-Cook Medical, Inc. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
November 29, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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Other clearances for product code GCA

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  • K173414 — Advance Biliary Balloon Catheter (June 22, 2018)
  • K170292 — Tri-Ex Extraction Balloon With Multiple Sizing (September 20, 2017)
  • K063677 — FUSION QUATTRO EXTRACTION BALLOON XL (January 5, 2007)
  • K040129 — TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (February 27, 2004)