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510(k) K132233

K-PACK II NEEDLE - 27G X 3/4 THIN WALL by Terumo Europe N.V. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
July 18, 2013
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

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  • K150263 — K-Pack II Needle-21G x 2 (April 1, 2015)
  • K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (March 18, 2014)

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  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
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