510(k) clearance
Promisemed X-Safety Pen Needle
- 510(k) number
- K261719
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Decision date
- Aug 25, 2026
- Date received
- May 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- FMI
- Device type
- Needle, Hypodermic, Single Lumen
- Device class
- Class II
- Regulation
- 21 CFR 880.5570
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN