Home / 510(k) Clearances / K212226

510(k) K212226

DR Safety Syringe, Sterile Hypodermic needle for Single use by Zhuhai DR Medical Instruments Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2021
Date Received
July 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Zhuhai DR Medical Instruments Co., Ltd.

  • K251788 — Extension tube (March 5, 2026)

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)