Home / 510(k) Clearances / K221073

510(k) K221073

Sterile Hypodermic Syringes for Single Use with Safety Needles by Sichuan Prius Biotechnology Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2022
Date Received
April 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Sichuan Prius Biotechnology Co., Ltd.

  • K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (November 21, 2022)
  • K221069 — Infusion Sets for Single Use with Needles (November 21, 2022)
  • K221075 — Infusion Sets for Single Use (November 21, 2022)
  • K221080 — Sterile Safety Hypodermic Needles for Single Use (October 4, 2022)
  • K221066 — Sterile Hypodermic Needles for Single Use (October 4, 2022)
  • K221079 — Sterile Hypodermic Syringes for Single Use (October 4, 2022)
  • K221068 — Sterile Hypodermic Syringes for Single Use with Needles (October 4, 2022)
  • K210908 — Surgical Mask (September 26, 2021)

Other clearances for product code MEG

  • K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (February 18, 2026)
  • K250847 — VaporShield (December 12, 2025)
  • K230287 — SaviSafe Safety Device (November 21, 2023)
  • K231165 — Shina Syringe; Shina Safety Syringe (October 27, 2023)
  • K231907 — Medline Safety Insulin and TB Syringes (October 18, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K220114 — PowerPAK Syringe (January 25, 2023)
  • K221981 — SafeR Syringe and SafeR Sting (December 29, 2022)
  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
  • K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with N (November 1, 2022)