Home / 510(k) Clearances / K193344

510(k) K193344

Tri-Ex Extraction Balloon with Multiple Sizing by Wilson-Cook Medical, Inc. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
December 3, 2019
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

Other clearances by Wilson-Cook Medical, Inc.

  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (January 17, 2025)
  • K213356 — Entuit PEG, Entuit PEGJ (January 20, 2022)
  • K212323 — Instinct Plus Endoscopic Clipping Device (August 25, 2021)
  • K201322 — Entuit Nasal Jejunal Feeding Tube (June 17, 2020)
  • K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (January 30, 2020)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)

Other clearances for product code GCA

  • K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23 (February 26, 2024)
  • K212582 — SpyGlass Discover Balloon Dilation Catheter (May 6, 2022)
  • K210660 — Stone Retrieval Balloon Catheter (April 27, 2021)
  • K200173 — Stone Retrieval Balloon (May 1, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing (July 6, 2018)
  • 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)