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510(k) K243309

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) by Terumo Europe N.V. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2025
Date Received
October 21, 2024
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 Terumo Europe N.V.

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  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 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)

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  • 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)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)
  • K243806 — Safety Winged Blood Collection Sets (January 10, 2025)