FDA 510(k)

GEM ZIPCLIP

Número K: K242541 · 2025-01-15

RequerenteSynovis Micro Companies Alliance A Subsidiary of Baxter Int

Data da decisão2025-01-15

Código do produtoFZP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GEM ZIPCLIP is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance A Subsidiary of Baxter Int. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K242541. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GEM ZIPCLIP?

GEM ZIPCLIP is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is Synovis Micro Companies Alliance A Subsidiary of Baxter Int. The 510(k) number is K242541.

When did GEM ZIPCLIP receive FDA 510(k) clearance?

GEM ZIPCLIP received FDA 510(k) clearance on 2025-01-15, under 510(k) number K242541.

Who is the listed applicant for GEM ZIPCLIP?

The FDA 510(k) record lists Synovis Micro Companies Alliance A Subsidiary of Baxter Int as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM ZIPCLIP?

The FDA product code for GEM ZIPCLIP is FZP.

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