Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

SteriLance Medical (Suzhou), Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories4
Latest FDA decision2026-07-06
TypeNumberDevice NameCodeDateActions
510(k) K260122 Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL2026-07-06 View
510(k) K261634 Disposable Blood Lancet (Soft)QRK2026-06-12 View
510(k) K244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)QRK2025-02-26 View
510(k) K244036 Heel Incision Safety Lancet (SteriHeel 2)FMK2025-02-26 View
510(k) K233796 Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)FMK2024-01-16 View
510(k) K221521 Disposable Safety LancetFMK2022-10-28 View
510(k) K221507 Disposable Blood LancetQRK2022-08-31 View
510(k) K221970 Lancing deviceQRL2022-08-30 View
510(k) K210745 Heel Incision Safety LancetFMK2021-08-26 View
510(k) K153706 Insulin Pen NeedleFMI2016-08-29 View
↑