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510(k) K243581

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) by Terumo Europe N.V. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
November 14, 2024
Clearance Type
Traditional
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 Terumo Europe N.V.

  • 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)
  • K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M) (October 18, 2023)
  • K212095 — SurGuard3 Safety Hypodermic Needle (August 22, 2022)
  • K192057 — K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ult (October 11, 2019)
  • K161606 — Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (February 10, 2017)
  • K151398 — K-Pack II Needle - 29G x 5/16 Thin Wall (June 25, 2015)
  • K150263 — K-Pack II Needle-21G x 2 (April 1, 2015)
  • K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (March 18, 2014)
  • K133867 — SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (February 5, 2014)

Other clearances for product code FMI

  • 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)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)
  • K243806 — Safety Winged Blood Collection Sets (January 10, 2025)