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510(k) K252098

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) by Methyl Co., Ltd. — Product Code MEG

K252098 is an FDA 510(k) premarket notification submitted by Methyl Co., Ltd. for the device "PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)". The FDA issued a decision of Substantially Equivalent on February 18, 2026. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2026
Date Received
July 3, 2025
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

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  • 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)
  • K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syring (October 7, 2022)

FDA data resources