K232165
- 510(k) number
- K232165
- Device name
- Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
- Applicant
- Berpu Medical Technology Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2024-02-01
- Date received
- 2023-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232165.pdf
Official FDA record: K232165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.