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510(k) K251890

Disposable Ureteral Stents by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FAD

K251890 is an FDA 510(k) premarket notification submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. for the device "Disposable Ureteral Stents". The FDA issued a decision of Substantially Equivalent on February 20, 2026. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Zhejiang Chuangxiang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
June 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

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

  • K253132 — Single use stone retrieval balloons (March 6, 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 FAD

  • K251469 — Endura™ Ureteral Stent and Stent Set (December 19, 2025)
  • K243039 — Ureteral Stents (AF-D series) (June 18, 2025)
  • K243830 — Disposable ureteral stent (May 14, 2025)
  • K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDriv (April 15, 2025)
  • K232920 — RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent (March 22, 2024)
  • K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima AP (November 10, 2022)
  • K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone doub (June 8, 2022)
  • K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Ki (March 17, 2022)
  • K213186 — NovoFlow Reinforced Ureteral Stent (February 16, 2022)
  • K212868 — JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (January 26, 2022)

FDA data resources