K242741
- 510(k) number
- K242741
- Device name
- ACE Cannula
- Applicant
- Ace Medical Industry Co., Ltd. KR
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2025-01-08
- Date received
- 2024-09-11
- 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: K242741.pdf
Official FDA record: K242741
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.