Home / 510(k) Clearances / K192551

510(k) K192551

1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle by Jiangsu Caina Medical Co.,Ltd — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2020
Date Received
September 17, 2019
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 Jiangsu Caina Medical Co.,Ltd

  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)
  • K233190 — ENFit Adaptor (January 18, 2024)
  • K230635 — Pen Needle (June 2, 2023)
  • K222834 — Safety Push Button Blood Collection Set (January 5, 2023)
  • K221406 — Vented Vial Transfer Pin (October 28, 2022)
  • K222155 — Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket sy (September 16, 2022)
  • K220184 — Pump Alignment Syringe (July 21, 2022)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K210217 — Needleless Connector (May 17, 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)