Home / 510(k) Clearances / K232752

510(k) K232752

Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2024
Date Received
September 8, 2023
Clearance Type
Traditional
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 Jiangsu Vedkang Medical Science and Technology Co., Ltd.

  • K232825 — Disposable Sphincterotome (March 29, 2024)
  • K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter) (February 15, 2024)
  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K222146 — Disposable Endoscopic Hemoclip (March 28, 2023)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K213914 — Injection Needle (July 29, 2022)

Other clearances for product code GCA

  • 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)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
  • 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)