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FDA 510(k)

Disposable Safety Lancet

K-Number: K221521 · 2022-10-28

Decision Date2022-10-28
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Safety Lancet 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 2022-10-28 under 510(k) number K221521. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Safety Lancet?

Disposable Safety Lancet is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221521.

When did Disposable Safety Lancet receive FDA 510(k) clearance?

Disposable Safety Lancet received FDA 510(k) clearance on 2022-10-28, under 510(k) number K221521.

Who is the listed applicant for Disposable Safety Lancet?

The FDA 510(k) record lists SteriLance Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Safety Lancet?

The FDA product code for Disposable Safety Lancet is FMK.

Other records listing SteriLance Medical (Suzhou), Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: FMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.