510(k) clearance
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
- 510(k) number
- K262631
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Decision date
- Aug 25, 2026
- Date received
- Jul 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QRK
- Device type
- Single Use Only Blood Lancet Without 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
- Suzhou, CN