K240355
- 510(k) number
- K240355
- Device name
- FROG (Filter Removal of Glass)
- Applicant
- Carrtech Corp MD · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-04-18
- Date received
- 2024-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240355.pdf
Official FDA record: K240355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.