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510(k) K254273

Verisafe Safety Sterile Needles (SSN) by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
December 30, 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 Promisemed Hangzhou Meditech Co., Ltd.

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  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K243806 — Safety Winged Blood Collection Sets (January 10, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K242632 — Verifine® Pen Needles (September 26, 2024)
  • K234124 — Single Use Hemoclips (July 12, 2024)
  • K231792 — VeriSafe Safety sterile syringes (September 28, 2023)
  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)

Other clearances for product code FMI

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  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
  • K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (July 8, 2025)
  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)