K261719
- 510(k) number
- K261719
- Device name
- Promisemed X-Safety Pen Needle
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-08-25
- Date received
- 2026-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261719.pdf
Official FDA record: K261719
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.