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510(k) K230925

Disposable Injection Needle AF series by Alton (Shanghai) Medical Instruments Co., Ltd. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
April 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

Other clearances by Alton (Shanghai) Medical Instruments Co., Ltd.

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  • 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)

Other clearances for product code FBK

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  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K241595 — EzVu Visual Vasopressor injector (EV-19) (February 27, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K232200 — Disposable Injection Needles (April 12, 2024)
  • K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) (March 8, 2024)
  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)
  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)
  • K221054 — CORE-INJECTOR (December 21, 2022)