Home / 510(k) Clearances / K022406

510(k) K022406

EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET by Exelint Intl. Co. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
July 23, 2002
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 Exelint Intl. Co.

  • K092172 — EXEL I.V. EXTENSION SET (January 4, 2010)
  • K052103 — EXEL SECURE TOUCH II SAFETY SYRINGE (October 19, 2005)
  • K031500 — EXCEL PRIMARY SOLUTION SET (July 25, 2003)
  • K011754 — EXEL SECURETOUCH PTP SYRINGE (January 22, 2003)
  • K020533 — EXEL VACULET BLOOD COLLECTION SET (December 2, 2002)
  • K011757 — EXEL COMFORTPOINT INSULIN PEN NEEDLE (January 23, 2002)
  • K012879 — EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE (January 17, 2002)
  • K013037 — EXCEL A.V FISUTAL NEEDLE SET (December 7, 2001)
  • K011405 — EXEL INJECTION PLUG WITH CAP (September 27, 2001)
  • K010404 — EXEL I.V. ADMINISTRATION SET (August 30, 2001)

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)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)