FDA 510(k)

穿刺器（PressGo, LDE3, LDE3AST, LDE5, EasyStep）

K号: K260122 · 2026-07-06

决定日期2026-07-06

产品代码QRL

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决定实质等同

器械摘要

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2026-07-06 under 510(k) number K260122. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)?

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K260122.

When did Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) receive FDA 510(k) clearance?

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) received FDA 510(k) clearance on 2026-07-06, under 510(k) number K260122.

Who is the listed applicant for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)?

FDA 510(k)记录将SteriLance Medical (Suzhou), Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)?

The FDA product code for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) is QRL.

列明SteriLance Medical (Suzhou), Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262631一次性血刺针（Soft Pro，Softsure，Softsure Pro，Softsense）K261634一次性血刺针（软）K244036足跟切口安全刀片（SteriHeel 2）K244031一次性血刺针（软Pro）；一次性血刺针（Softsure）；一次性血刺针（Softsure Pro）；一次性血刺针（Softsense）K233796一次性安全注射针（Impress）；一次性安全注射针（Impress Pro）；一次性安全注射针（Lite4）；一次性血注射针（Elite）；一次性血注射针（Elite Pro）K221521一次性安全注射针

查看所有 11 个设备 →

相关器械（代码：QRL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262135刺针Tianjin Huahong Technology Co., Ltd.K262211lancetTianjin Huahong Technology Co., Ltd.K253706刺针 (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 刺针装置Ascensia Diabetes Care U.S., Inc.K243306lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); 刺针 (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.K232912Facet Aurora 可重复使用注射针座Facet Technologies, LLC

官方来源

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