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510(k) K253132

Single use stone retrieval balloons by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2026
Date Received
September 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Zhejiang Chuangxiang Medical Technology Co., Ltd.

  • K251890 — Disposable Ureteral Stents (February 20, 2026)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K212669 — Single Use Hemoclip (May 27, 2022)
  • K220065 — Single Use Ureteral Access Sheath (May 25, 2022)
  • K212668 — Sclerotherapy Needle (February 23, 2022)
  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K192258 — Disposable Valve Sets (December 30, 2019)
  • K173758 — Disposable Biopsy Valve (May 14, 2018)

Other clearances for product code FGE

  • K253987 — BARE Wireguided Balloon Dilation Catheter (1235) (March 13, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)
  • K241801 — Tornus ES (December 17, 2024)