Medical Device Manufacturer · CN , Suzhou

SteriLance Medical (Suzhou), Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2016

Recent clearances: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense), Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep), Disposable Blood Lancet (Soft)

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - SteriLance Medical (Suzhou), Inc. General & Plastic Surgery ✕

10 devices

1-10 of 10

Cleared Aug 25, 2026

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

General & Plastic Surgery · 27d

Cleared Jul 06, 2026

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

General & Plastic Surgery · 172d

Cleared Jun 12, 2026

Disposable Blood Lancet (Soft)

General & Plastic Surgery · 25d

Cleared Feb 26, 2025

Disposable Blood Lancet (Soft Pro)

General & Plastic Surgery · 58d

Cleared Feb 26, 2025

Heel Incision Safety Lancet (SteriHeel 2)

General & Plastic Surgery · 58d

Cleared Jan 16, 2024

Disposable safety lancet (Impress)

General & Plastic Surgery · 48d

Cleared Oct 28, 2022

Disposable Safety Lancet

General & Plastic Surgery · 156d

Cleared Aug 31, 2022

Disposable Blood Lancet

General & Plastic Surgery · 100d

Cleared Aug 30, 2022

General & Plastic Surgery · 56d

Cleared Aug 26, 2021

Heel Incision Safety Lancet

General & Plastic Surgery · 167d