Home / 510(k) Clearances / K252908

510(k) K252908

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle by Sandstone Medical (Suzhou), Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2026
Date Received
September 12, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Sandstone Medical (Suzhou), Inc.

  • K210864 — Safety Pen Needle (February 17, 2022)
  • K193422 — Easydrip Pen Needle, Easydrip Plus Pen Needle (February 2, 2021)

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  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
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  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
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