K252631
- 510(k) number
- K252631
- Device name
- Profoject Disposable Needle
- Applicant
- CMT Health PTE., Ltd. SG
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-10-16
- Date received
- 2025-08-20
- 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: K252631.pdf
Official FDA record: K252631
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.