Home / 510(k) Clearances / K230061

510(k) K230061

Insulin Syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2023
Date Received
January 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

  • K234024 — HWJECT Auto-disable syringe (March 19, 2024)
  • K230043 — Insulin Pen Needle (September 20, 2023)
  • K223323 — Blood Collection Needle (with/without Needle Holder) (March 24, 2023)
  • K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle (November 4, 2022)
  • K222141 — Safety Blood Collection Needle (Without Needle Holder) (October 21, 2022)
  • K220900 — Safety Blood Collection Needles with/without Needle Holder (August 10, 2022)
  • K220083 — LDV((Low Dead Volume )Syringe (May 25, 2022)
  • K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Colle (April 12, 2022)
  • K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (October 18, 2021)
  • K202188 — Safety Blood Collection Sets for Single Use (February 19, 2021)

Other clearances for product code FMF

  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K252033 — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (July 25, 2025)