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510(k) K230712

SG Lanset I, SG Lancets, Soft Lancets by Sewon Medical Co. — Product Code QRK

K230712 is an FDA 510(k) premarket notification submitted by Sewon Medical Co. for the device "SG Lanset I, SG Lancets, Soft Lancets". The FDA issued a decision of Substantially Equivalent on December 6, 2023. The device falls under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2023
Date Received
March 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances for product code QRK

  • K261634 — Disposable Blood Lancet (Soft) (June 12, 2026)
  • K250016 — droplet® personal lancets (July 1, 2025)
  • K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
  • K242622 — Sterile Lancets for Single Use (October 28, 2024)
  • K241810 — MICROLET®NEXT Lancet (August 15, 2024)
  • K232330 — Lancing System (January 4, 2024)
  • K230310 — STAT Medical Device Lancing System (September 8, 2023)
  • K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro (June 13, 2023)
  • K222617 — EasyTouch Lancing Device (March 21, 2023)
  • K223815 — ONE DROP Lancing Device (February 15, 2023)

FDA data resources