K230759 is an FDA 510(k) clearance for the SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro). 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 Bosungmeditech Co., Ltd. (Wonju, KR). The FDA issued a Cleared decision on June 13, 2023, 85 days after receiving the submission on March 20, 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 | K230759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2023 |
| Decision Date | June 13, 2023 |
| Days to Decision | 85 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. |