K250192
- 510(k) number
- K250192
- Device name
- Verisafe Safety Retractable Insulin Syringes
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-12-10
- Date received
- 2025-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K250192.pdf
Official FDA record: K250192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.