510(k) clearance
Safety lancet (XL)
- 510(k) number
- K262526
- Applicant
- Tianjin Huahong Technology Co., Ltd.
- Decision date
- Sep 13, 2026
- Date received
- Jul 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FMK
- Device type
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class II
- Regulation
- 21 CFR 878.4850
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Tianjin, CN