K242664 is an FDA 510(k) clearance for the gentleheel? Adult Incision Device, 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 November 5, 2024, 62 days after receiving the submission on September 4, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.
| 510(k) Number | K242664 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 2024 |
| Decision Date | November 05, 2024 |
| Days to Decision | 62 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. |