K254273
- 510(k) number
- K254273
- Device name
- Verisafe Safety Sterile Needles (SSN)
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-04-16
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K254273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.