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510(k) K243039

Ureteral Stents (AF-D series) by Alton (Shanghai) Medical Instruments Co., Ltd. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
September 27, 2024
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 Alton (Shanghai) Medical Instruments Co., Ltd.

  • K242635 — Endoscopic Distal Attachment (AF-D series) (May 30, 2025)
  • K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K231633 — Disposable Hemoclip (AF series) (January 11, 2024)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)

Other clearances for product code FAD

  • K251890 — Disposable Ureteral Stents (February 20, 2026)
  • K251469 — Endura™ Ureteral Stent and Stent Set (December 19, 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)