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510(k) K251089

EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle by Exelint International, Co. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
April 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Exelint International, Co.

  • K152183 — EXELINT SecureTouch Safety Hypodermic Needle (November 2, 2015)
  • K101309 — EXELINT ALUMINUM HUB BLUNT NEEDLES (October 20, 2010)
  • K020189 — EXEL BUTTERFLY SCALP VEIN SET (March 27, 2003)
  • K010197 — EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (May 14, 2001)
  • K003627 — EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET (February 8, 2001)
  • K001496 — A.V. FISTULA NEEDLE (August 1, 2000)

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