FDA 510(k)

足跟切口安全刀片（SteriHeel 2）

K号: K244036 · 2025-02-26

决定日期2025-02-26

产品代码FMK

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决定实质等同

器械摘要

Heel Incision Safety Lancet (SteriHeel 2) 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 2025-02-26 under 510(k) number K244036. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Heel Incision Safety Lancet (SteriHeel 2)?

Heel Incision Safety Lancet (SteriHeel 2) is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K244036.

When did Heel Incision Safety Lancet (SteriHeel 2) receive FDA 510(k) clearance?

Heel Incision Safety Lancet (SteriHeel 2) received FDA 510(k) clearance on 2025-02-26, under 510(k) number K244036.

Who is the listed applicant for Heel Incision Safety Lancet (SteriHeel 2)?

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 Heel Incision Safety Lancet (SteriHeel 2)?

The FDA product code for Heel Incision Safety Lancet (SteriHeel 2) is FMK.

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。

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官方来源

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