K220917 is an FDA 510(k) clearance for the gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler. This device is classified as a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II - Special Controls, product code FMK).
Submitted by Gri-Alleset, Inc. (Flowery Branch, US). The FDA issued a Cleared decision on May 18, 2022, 49 days after receiving the submission on March 30, 2022.
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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use..
| 510(k) Number | K220917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2022 |
| Decision Date | May 18, 2022 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMK — Single Use Only Blood Lancet With 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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use. |