K251138
- 510(k) number
- K251138
- Device name
- Promisemed Safety Huber Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- PTI — Non-Coring (Huber) Needle
- Decision date
- 2025-05-13
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251138.pdf
Official FDA record: K251138
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.