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FDA 510(k)

SG Lanset I, SG Lancets, Soft Lancets

K-Number: K230712 · 2023-12-06

ApplicantSewon Medical Co.
Decision Date2023-12-06
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SG Lanset I, SG Lancets, Soft Lancets is a medical device manufactured by Sewon Medical Co.. It received FDA 510(k) clearance on 2023-12-06 under approval number K230712. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SG Lanset I, SG Lancets, Soft Lancets?

SG Lanset I, SG Lancets, Soft Lancets is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by Sewon Medical Co.. The 510(k) number is K230712.

When was SG Lanset I, SG Lancets, Soft Lancets approved by the FDA?

SG Lanset I, SG Lancets, Soft Lancets received FDA 510(k) clearance on 2023-12-06, under approval number K230712.

What company makes SG Lanset I, SG Lancets, Soft Lancets?

SG Lanset I, SG Lancets, Soft Lancets is manufactured by Sewon Medical Co..

What is the FDA product code for SG Lanset I, SG Lancets, Soft Lancets?

The FDA product code for SG Lanset I, SG Lancets, Soft Lancets is QRK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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