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510(k) K052103

EXEL SECURE TOUCH II SAFETY SYRINGE by Exelint Intl. Co. — Product Code MEG

K052103 is an FDA 510(k) premarket notification submitted by Exelint Intl. Co. for the device "EXEL SECURE TOUCH II SAFETY SYRINGE". The FDA issued a decision of Substantially Equivalent on October 19, 2005. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Exelint Intl. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2005
Date Received
August 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Exelint Intl. Co.

  • K092172 — EXEL I.V. EXTENSION SET (January 4, 2010)
  • 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)
  • K022406 — EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET (September 30, 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 MEG

  • K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (February 18, 2026)
  • K250847 — VaporShield (December 12, 2025)
  • K230287 — SaviSafe Safety Device (November 21, 2023)
  • K231165 — Shina Syringe; Shina Safety Syringe (October 27, 2023)
  • K231907 — Medline Safety Insulin and TB Syringes (October 18, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K220114 — PowerPAK Syringe (January 25, 2023)
  • K221981 — SafeR Syringe and SafeR Sting (December 29, 2022)
  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
  • K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with N (November 1, 2022)

FDA data resources