Home / 510(k) Clearances / K202432

510(k) K202432

MiniLoad Syringe by Ocuject, LLC — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
August 25, 2020
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 Ocuject, LLC

  • K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Saf (October 25, 2024)
  • K233343 — SteriCap Safety Needle; VitreJect Safety Needle (November 27, 2023)
  • K230959 — VitreJect® Needle; OcuSafe® Needle (September 14, 2023)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K212544 — MiniLoad Syringe (October 13, 2021)
  • K212805 — SteriCap Mini Needle and Standard Needles (September 30, 2021)
  • K170768 — Mini Needle (July 10, 2017)

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)