K243232 is an FDA 510(k) clearance for the GripMate. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Synthon Hispania S.L. (Sant Boi De Llobregat, ES). The FDA issued a Cleared decision on December 2, 2024, 54 days after receiving the submission on October 9, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K243232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2024 |
| Decision Date | December 02, 2024 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH - Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |