Chrysalis Intelligence · Sponsors · SteriLance Medical (Suzhou), Inc.

SteriLance Medical (Suzhou), Inc.

Suzhou, CN · 10 510(k) clearances

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Total clearances
10
2021-08-26 → 2026-08-25
Last 12 months
3
Product codes
3
Most recent
2026-08-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 4 2026-08-25
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 4 2025-02-26
QRL Multiple Use Blood Lancet For Single Patient Use Only Class II General, Plastic Surgery 2 2026-07-06
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-08-25 K262631 Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) QRK Class II General, Plastic Surgery
2026-07-06 K260122 Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) QRL Class II General, Plastic Surgery
2026-06-12 K261634 Disposable Blood Lancet (Soft) QRK Class II General, Plastic Surgery
2025-02-26 K244036 Heel Incision Safety Lancet (SteriHeel 2) FMK Class II General, Plastic Surgery
2025-02-26 K244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) QRK Class II General, Plastic Surgery
2024-01-16 K233796 Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) FMK Class II General, Plastic Surgery
2022-10-28 K221521 Disposable Safety Lancet FMK Class II General, Plastic Surgery
2022-08-31 K221507 Disposable Blood Lancet QRK Class II General, Plastic Surgery
2022-08-30 K221970 Lancing device QRL Class II General, Plastic Surgery
2021-08-26 K210745 Heel Incision Safety Lancet FMK Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-09-08 09:57 · Last ingest 2026-09-08T13:56:10.065722 · Pipeline: Chrysalis Intelligence