FDA 510(k)

AEON Endoscopic Stapler

Número K: K222210 · 2023-04-21

Data da decisão2023-04-21

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AEON Endoscopic Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Lexington Medical, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K222210. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AEON Endoscopic Stapler?

AEON Endoscopic Stapler is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K222210.

When did AEON Endoscopic Stapler receive FDA 510(k) clearance?

AEON Endoscopic Stapler received FDA 510(k) clearance on 2023-04-21, under 510(k) number K222210.

Who is the listed applicant for AEON Endoscopic Stapler?

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

What is the FDA product code for AEON Endoscopic Stapler?

The FDA product code for AEON Endoscopic Stapler is GDW.

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Outros registros que listam Lexington Medical, Inc. como candidato(a)

K251482AEON® Endoscopic Powered Stapler K234039AEON Endoscopic Powered Stapler (Curto/AEPH060); AEON Endoscopic Powered Stapler (Médio/AEPH160); AEON Endoscopic Powered Stapler (Longo/AEPH260)K201882AEON Endoscopic Stapler K192235AEON Instrumentos Laparoscópicos K182380AEON Endoscopic Stapler K180114AEON Saco de Recuperação

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Dispositivos Relacionados (Código: GDW)

Fonte oficial

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