K243232
- 510(k) number
- K243232
- Device name
- GripMate
- Applicant
- Synthon Hispania S.L. ES
- Product code
- KZH — Introducer, Syringe Needle
- Decision date
- 2024-12-02
- Date received
- 2024-10-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243232.pdf
Official FDA record: K243232
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.