Disposable Blood Lancet (Soft)— 510(k) K261634
Substantially EquivalentSteriLance Medical (Suzhou), Inc.
FDA 510(k) clearance K261634 for Disposable Blood Lancet (Soft), Substantially Equivalent on 2026-06-12. Applicant: SteriLance Medical (Suzhou), Inc.. Device class: 2.
Summary
SteriLance Medical (Suzhou)'s Disposable Blood Lancet (Soft) is filed under QRK, single-use-only blood lancets without an integral sharps injury prevention feature. The record doesn't say what "Soft" refers to or give gauges.
Class II, 21 CFR 878.4850. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
SteriLance filed from Suzhou, China. Review took 25 calendar days (May 18 to June 12, 2026).
Clearance details
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Product code
- Product code QRK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Suzhou, CN
Recent devices under product code QRK
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