FDA 510(k)

Safety Lancet

Número K: K222801 · 2023-01-25

Data da decisão2023-01-25

Código do produtoFMK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Safety Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt AG & CO KG. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222801. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Safety Lancet?

Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Sarstedt AG & CO KG. The 510(k) number is K222801.

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

Safety Lancet received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222801.

Who is the listed applicant for Safety Lancet?

The FDA 510(k) record lists Sarstedt AG & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Lancet?

The FDA product code for Safety Lancet is FMK.

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