510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230712Substantially Equivalent

SG Lanset I, SG Lancets, Soft Lancets

Sewon Medical Co., Busan-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230712 is the FDA 510(k) clearance record for SG Lanset I, SG Lancets, Soft Lancets, a class II device, cleared for Sewon Medical Co. on under FDA product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature). FDA's definition for product code QRK reads: "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". FDA records list one 510(k) clearance for Sewon Medical Co. As of , FDA records show no recalls naming K230712.

Clearance record

Decision date
Received
(266 days to decision)
Product code
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sewon Medical Co. Na-104, 5, Garak-Daero 373beon-Gil, Gangseo-Gu, Busan-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRK

Trailing 12 months
2 clearances under product code QRK in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QRK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260