FDA 510(k)

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

Numéro K : K230255 · 2023-03-28

DemandeurStryker Sustainability Solutions

Date de décision2023-03-28

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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 2023-03-28 under 510(k) number K230255. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2023-03-28. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K230255.

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 2023-03-28, under 510(k) number K230255.

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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Source officielle

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