K230712 is an FDA 510(k) clearance for the SG Lanset I, SG Lancets, Soft Lancets. This device is classified as a Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (Class II - Special Controls, product code QRK).
Submitted by Sewon Medical Co. (Busan-Si, KR). The FDA issued a Cleared decision on December 6, 2023, 266 days after receiving the submission on March 15, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4850. 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..
| 510(k) Number | K230712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2023 |
| Decision Date | December 06, 2023 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QRK - Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4850 |
| Definition | 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. |