FDA 510(k)

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)

Número K: K220481 · 2022-05-25

RequerenteStryker Sustainability Solutions

Data da decisão2022-05-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220481. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K220481.

When did Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) receive FDA 510(k) clearance?

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220481.

Who is the listed applicant for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)?

The FDA product code for Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) is GEI.

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